Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a… — Class II medical device recall Z-0075-2015
Terminated recall by Biomet, Inc., reported 2014-10-22, distributed nationwide. An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etche
| Recall number | Z-0075-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-09-24 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN, NL |
| Quantity | 6 |
| Lot numbers | 555011 |
| Model numbers | 414837 |
Product
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components.
Reason for recall
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
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-0075-2015. 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.