Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 04546540197771; Lot code: K074846
- 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:
- Stryker GmbH
- Reason for Recall:
- The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Product Codes/Lot Numbers:
GTIN 04546540197771; Lot code: K074846
Distribution:
Distributed in: US, AL, FL, KY, NC, TN, UT, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2393-2018
Related Recalls
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Stryker GmbH
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.