FDA Device recall Z-1846-2013
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A si…
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A si… by Stryker Howmedica Osteonics, citing stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1846-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-21 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | IL, KY, TN |
Product
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Reason
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Identifiers
| code_info | Catalog Number- 33250400S Catalog Number 33250360S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1846-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.