Device product
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Z-0972-2019
Product summary
- Event
- Event 81118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52
- Official record key
device-enforcement:Z-0972-2019
Official wording
Reason: The product was potentially being packaged without a taper adapter.
Code information: Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
Distribution pattern: US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Derived failure modes
-
Unknown
The product was potentially being packaged without a taper adapter.