Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comp…

Recall date
December 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0972-2019
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.

Why it was recalled

The product was potentially being packaged without a taper adapter.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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