GMK Hinge knee prosthesis — Class II medical device recall Z-0275-2016
Terminated recall by Medacta Usa, reported 2015-11-25, distributed in IL, OH, UT. Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm
| Recall number | Z-0275-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa, Chicago, IL, United States |
| Recall initiated | 2015-04-17 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-01-05 |
| Distributed | IL, OH, UT |
| Countries outside the US | AT, AU, CH, ES, FR |
| Quantity | 4 units |
| Lot numbers | 145129 |
| Model numbers | 02.09.TA410 |
Product
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Reason for recall
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
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-0275-2016. 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.