Device product
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.
Z-2685-2020
Product summary
- Event
- Event 85920
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2685-2020
Official wording
Reason: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Code information: Model: 71655139 Lot: 19BM13592A
Distribution pattern: International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Derived failure modes
-
Manufacturing or process control
manufacturing error