Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With… — Class II medical device recall Z-1615-2020
Terminated recall by Biomet, Inc., reported 2020-04-08. Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged w
| Recall number | Z-1615-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-02-25 |
| Classified | 2020-03-31 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2020-08-05 |
| Quantity | 21 units |
| Lot numbers | 410420 |
| Model numbers | 010000589 |
Product
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Reason for recall
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1615-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.