FDAApril 17, 2015device
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
What to do
FDA enforcement status: Terminated
Brands named
medacta
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device2023-03-08
- FDANextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid2022-10-27
- FDAGMK Efficiency - GMK Sphere CR Insert Instrument Set Size 12022-04-13
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