Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number...
FDA Recall #Z-0972-2019 — Class II — December 21, 2018
Product Description
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.
Reason for Recall
The product was potentially being packaged without a taper adapter.
Recalling Firm
Zimmer Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
52
Distribution
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated