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;

Class I - Dangerous

🏥 Medical Devices Recalled: November 3, 2025 Orthofix U.S. Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Lot Code: All Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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 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;

Product Codes/Lot Numbers:

Lot Code: All Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550