Device product
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Z-0093-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0093-2021
Official wording
Reason: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Code information: Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110
Distribution pattern: US Nationwide distribution including in the states of CO, MN, OH, WY.
Derived failure modes
-
Unknown
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters