Medacta GMK HINGE — Class II medical device recall Z-2661-2017
Terminated recall by Medacta Usa Inc, reported 2017-07-12, distributed in AZ, CA, NC. One lot of product does not include a screw for attachment to the tibial base plate.
| Recall number | Z-2661-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2017-05-19 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-05-29 |
| Distributed | AZ, CA, NC |
| Countries outside the US | FR, IL |
| Quantity | 4 units |
| Lot numbers | 163646 |
| Model numbers | 02.09.0223H |
Product
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Reason for recall
One lot of product does not include a screw for attachment to the tibial base plate.
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-2661-2017. 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.