Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
- 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 Howmedica Osteonics Corp.
- Reason for Recall:
- Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
Product Codes/Lot Numbers:
Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0065-2015
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