FDAApril 13, 2022device
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
What to do
FDA enforcement status: Terminated
Brands named
medacta
UPCs
07630971252509
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
- FDAMedacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or repara...2019-11-04
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