DISCOVERY ELBOW prosthesis — Class II medical device recall Z-1925-2014
Terminated recall by Biomet, Inc., reported 2014-07-02, distributed nationwide. Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when t
| Recall number | Z-1925-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2014-06-26 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2015-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | foreign material |
| Lot numbers | M846640 |
| Model numbers | 114905 |
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Reason for recall
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
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-1925-2014. 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.