FDA-Device2019-03-13Class II
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.
Zimmer Biomet, Inc.
Hazard
The product was potentially being packaged without a taper adapter.
Sold states
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Affected count
52
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2019Don't want to check this manually?
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