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.
Other recalls by Medacta Usa
- Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.…
FDA Device · Class II · 2026-07-08 · Medacta Usa - MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa
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.