FDAOctober 24, 2017device
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
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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