Centered Glenosphere w/Screw — Class II medical device recall Z-0843-2024
Ongoing recall by FX SHOULDER, reported 2024-02-07, distributed nationwide. Centered glenosphere box may contain an eccentric glenosphere.
| Recall number | Z-0843-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FX SHOULDER, Dallas, TX, United States |
| Recall initiated | 2023-08-08 |
| Classified | 2024-01-29 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| UPC / GTIN / UDI-DI | 03701037309551 |
| Lot numbers | U0191 |
| Model numbers | 115-3210 |
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Reason for recall
Centered glenosphere box may contain an eccentric glenosphere.
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-0843-2024. 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.