FDAFDA · Food and drugs·Recall number Z-0972-2019
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.
Published March 13, 2019 · Recall initiated: December 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product was potentially being packaged without a taper adapter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
- Lot
- Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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