LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
- 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:
- Smith & Nephew, Inc.
- Reason for Recall:
- The incorrect Loctite adhesive was used to assemble the impactor heads.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
Product Codes/Lot Numbers:
Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
Distribution:
Distributed in: US, TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2625-2017
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Smith & Nephew
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Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.