Recall Z-0075-2015 ยท HWT Template
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.
| Date | Oct 16, 2014 (initiated Sep 24, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.