FDAFDA · Food and drugs·Recall number Z-2685-2020
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Published July 29, 2020 · Recall initiated: June 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- International distribution in the countries of Brazil, Colombia and United Arab Emirates.
- Lot
- Model: 71655139 Lot: 19BM13592A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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