🔍 RecallPedia

Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2025 Orthofix U.S. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6312SP 18257200150977 37-6312SP 18257200150977 37-6312SP 18257200150977 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7312SP 18257200151066 37-7312SP 18257200151066 37-7312SP 18257200151066 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8312SP 18257200151158 37-8312SP 18257200151158 37-8312SP 18257200151158 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9012SP 18257200150526 37-9012SP 18257200150526 37-9105SP 18257200150052 37-9105SP 18257200150052 37-9106SP 18257200150069 37-9106SP 18257200150069 37-9107SP 18257200150076 37-9107SP 18257200150076 37-9108SP 18257200150083 37-9108SP 18257200150083 37-9109SP 18257200150090 37-9109SP 18257200150090 37-9110SP 18257200150106 37-9110SP 18257200150106 37-9111SP 18257200150113 37-9111SP 18257200150113 37-9112SP 18257200150120 37-9112SP 18257200150120 37-9206SP 18257200150823 37-9206SP 18257200150823 37-9207SP 18257200150830 37-9207SP 18257200150830 37-9208SP 18257200150847 37-9208SP 18257200150847 37-9209SP 18257200150854 37-9209SP 18257200150854 37-9210SP 18257200150861 37-9210SP 18257200150861 37-9211SP 18257200150878 37-9211SP 18257200150878 37-9212SP 18257200150885 37-9212SP 18257200150885 37-9306SP 18257200151189 37-9306SP 18257200151189 37-9307SP 18257200151196 37-9307SP 18257200151196 37-9308SP 18257200151202 37-9308SP 18257200151202 37-9309SP 18257200151219 37-9309SP 18257200151219 37-9310SP 18257200151226 37-9310SP 18257200151226 37-9311SP 18257200151233 37-9311SP 18257200151233 37-9312SP 18257200151240 37-9312SP 18257200151240
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Orthofix U.S. LLC
Reason for Recall:
Labeling contains claims that are not consistently present.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic

Product Codes/Lot Numbers:

Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6209SP 18257200150588 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6210SP 18257200150595 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6211SP 18257200150601 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6212SP 18257200150618 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6306SP 18257200150915 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6307SP 18257200150922 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6308SP 18257200150939 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6309SP 18257200150946 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6310SP 18257200150953 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6311SP 18257200150960 37-6312SP 18257200150977 37-6312SP 18257200150977 37-6312SP 18257200150977 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7005SP 18257200150250 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7006SP 18257200150267 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7007SP 18257200150274 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7008SP 18257200150281 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7009SP 18257200150298 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7010SP 18257200150304 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7011SP 18257200150311 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7012SP 18257200150328 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7105SP 18257200149858 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7106SP 18257200149865 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7107SP 18257200149872 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7108SP 18257200149889 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7109SP 18257200149896 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7110SP 18257200149902 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7111SP 18257200149919 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7112SP 18257200149926 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7206SP 18257200150649 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7207SP 18257200150656 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7208SP 18257200150663 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7209SP 18257200150670 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7210SP 18257200150687 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7211SP 18257200150694 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7212SP 18257200150700 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7306SP 18257200151004 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7307SP 18257200151011 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7308SP 18257200151028 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7309SP 18257200151035 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7310SP 18257200151042 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7311SP 18257200151059 37-7312SP 18257200151066 37-7312SP 18257200151066 37-7312SP 18257200151066 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8005SP 18257200150359 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8006SP 18257200150366 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8007SP 18257200150373 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8008SP 18257200150380 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8009SP 18257200150397 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8011SP 18257200150410 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8012SP 18257200150427 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8015SP 18257200150403 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8105SP 18257200149957 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8106SP 18257200149964 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8107SP 18257200149971 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8108SP 18257200149988 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8109SP 18257200149995 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8110SP 18257200150007 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8111SP 18257200150014 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8112SP 18257200150021 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8206SP 18257200150731 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8207SP 18257200150748 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8208SP 18257200150755 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8209SP 18257200150762 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8210SP 18257200150779 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8211SP 18257200150786 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8212SP 18257200150793 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8306SP 18257200151097 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8307SP 18257200151103 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8308SP 18257200151110 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8309SP 18257200151127 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8310SP 18257200151134 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8311SP 18257200151141 37-8312SP 18257200151158 37-8312SP 18257200151158 37-8312SP 18257200151158 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9005SP 18257200150458 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9006SP 18257200150465 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9007SP 18257200150472 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9008SP 18257200150489 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9009SP 18257200150496 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9011SP 18257200150519 37-9012SP 18257200150526 37-9012SP 18257200150526 37-9105SP 18257200150052 37-9105SP 18257200150052 37-9106SP 18257200150069 37-9106SP 18257200150069 37-9107SP 18257200150076 37-9107SP 18257200150076 37-9108SP 18257200150083 37-9108SP 18257200150083 37-9109SP 18257200150090 37-9109SP 18257200150090 37-9110SP 18257200150106 37-9110SP 18257200150106 37-9111SP 18257200150113 37-9111SP 18257200150113 37-9112SP 18257200150120 37-9112SP 18257200150120 37-9206SP 18257200150823 37-9206SP 18257200150823 37-9207SP 18257200150830 37-9207SP 18257200150830 37-9208SP 18257200150847 37-9208SP 18257200150847 37-9209SP 18257200150854 37-9209SP 18257200150854 37-9210SP 18257200150861 37-9210SP 18257200150861 37-9211SP 18257200150878 37-9211SP 18257200150878 37-9212SP 18257200150885 37-9212SP 18257200150885 37-9306SP 18257200151189 37-9306SP 18257200151189 37-9307SP 18257200151196 37-9307SP 18257200151196 37-9308SP 18257200151202 37-9308SP 18257200151202 37-9309SP 18257200151219 37-9309SP 18257200151219 37-9310SP 18257200151226 37-9310SP 18257200151226 37-9311SP 18257200151233 37-9311SP 18257200151233 37-9312SP 18257200151240 37-9312SP 18257200151240

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0896-2026

Related Recalls

Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;

Orthofix U.S.

Class I - Dangerous

Labeling contains claims that are not consistently present.

Nov 3, 2025 Other Medical Devices Nationwide View Details →

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5¿ Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5¿ Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5¿ Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5¿ Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5¿ Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5¿ Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5¿ Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5¿ Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5¿ Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5¿ Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5¿ Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10¿ Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10¿ Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10¿ Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10¿ Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10¿ Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10¿ Lordotic;

Orthofix U.S.

Class I - Dangerous

Labeling contains claims that are not consistently present.

Nov 3, 2025 Other Medical Devices Nationwide View Details →

Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw

Orthofix U.S.

Class I - Dangerous

Labeling contains claims that are not consistently present.

Nov 3, 2025 Other Medical Devices Nationwide View Details →