Recalls / —
—#130262
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.
- FDA product code
- HWT — Template
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog Number: 414837 Lot Number: 555011
Why it was recalled
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46581
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Timeline
- Recall initiated
- 2014-09-24
- Posted by FDA
- 2014-10-16
- Terminated
- 2015-07-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #130262. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.