FDA Device recall Z-0275-2016
GMK Hinge knee prosthesis
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of GMK Hinge knee prosthesis by Medacta Usa, citing incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0275-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-17 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medacta Usa |
| Distribution | IL, OH, UT |
Product
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Reason
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Identifiers
| code_info | Lot: 145129 |
|---|
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-0275-2016%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.