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.
Reported: March 13, 2019 Initiated: December 21, 2018 #Z-0972-2019
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 52
- Distribution
- US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
- Location
- Warsaw, IN
Frequently Asked Questions
What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 52.
Why was this product recalled? ▼
The product was potentially being packaged without a taper adapter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Moderate. Recall number: Z-0972-2019.
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