Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intende
FDA device recall Z-0075-2015 · posted 2014-10-16 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- 6
- Distribution
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
- Date initiated
- 2014-09-24
- Date posted
- 2014-10-16
- Date terminated
- 2015-07-14
- Location
- Warsaw, IN
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