FDA Device recall Z-2685-2020
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out by Smith And Nephew, citing A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2685-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-24 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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.
Reason
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Identifiers
| code_info | Model: 71655139 Lot: 19BM13592A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2020%22
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