FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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.
- Recall number
- Z-0075-2015
- Recalling firm
- Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-09-24
- Posted
- 2014-10-16
- Terminated
- 2015-07-14
- Reason
- An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
- Root cause
- Process control
- Action
- Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letters dated September 24, 2014, via FedEx overnight to affected customers. The notification included a description of the reason for recall, instructions for responding to the formal recall notification, and affected product, actions to be taken. For questions call (574) 372-1570.
- Quantity
- 6
- Distribution
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
- Lot, serial or model codes
- Catalog Number: 414837 Lot Number: 555011
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28