FDANovember 4, 2019device
Medacta 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
What to do
FDA enforcement status: Terminated
Brands named
medacta
UPCs
07630040712613
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, 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 H18, REF 03.30.304, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device2023-03-08
- FDAMectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, 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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