Device product
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Z-1615-2020
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 85143
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-1615-2020
Official wording
Reason: Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Code information: Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420
Distribution pattern: International distribution - country of Netherland.s
Derived failure modes
-
Unknown
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.