Z-2685-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 24, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
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.
Reason for Recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Distribution Pattern
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Code Information
Model: 71655139 Lot: 19BM13592A