NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
What to do
FDA enforcement status: Terminated
Brands named
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
- FDAGMK Efficiency - GMK Sphere CR Insert Instrument Set Size 12022-04-13
- 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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