FDA Device recall Z-0093-2021
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: in…
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: in… by Biomet, citing product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0093-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-02 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Reason
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Identifiers
| code_info | Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110 |
|---|
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-0093-2021%22
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