GAMMA3 System Long Nail Kit — Class II medical device recall Z-1846-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-08-07, distributed in IL, KY, TN. Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
| Recall number | Z-1846-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-05-21 |
| Classified | 2013-07-31 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-10-14 |
| Distributed | IL, KY, TN |
| Quantity | 5 units |
| Model numbers | 33250360S, 33250400S |
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 for recall
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1846-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.