Recall Z-0075-2015
Biomet, Inc. · initiated September 24, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: 414837 Lot Number: 555011
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0075-2015
- Initiated
- September 24, 2014
- Posted by FDA
- October 16, 2014
- Terminated
- July 14, 2015
- Product code
- HWT – Template
- Quantity
- 6
- Distribution
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
- Recalling firm
- Biomet, Inc., Warsaw, IN