FDA Device recall Z-0972-2019
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Sh…
- FDA Device
- Class II
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Sh… by Zimmer Biomet, citing the product was potentially being packaged without a taper adapter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0972-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-21 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | AR, KY, WA |
Product
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
The product was potentially being packaged without a taper adapter.
Identifiers
| code_info | 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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0972-2019%22
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