Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 04546540715357, Lot Number K03CC4F
- 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 devices have a different inner diameter than the diameter specified on the outer box label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Product Codes/Lot Numbers:
GTIN 04546540715357, Lot Number K03CC4F
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2171-2021
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.