FDA Device recall Z-0075-2015
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and r…
- FDA Device
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and r… by Biomet, citing an investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0075-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-24 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
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
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Identifiers
| code_info | Catalog Number: 414837 Lot Number: 555011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0075-2015%22
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