Device 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.
Z-0075-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 69340
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0075-2015
Official wording
Reason: An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Code information: Catalog Number: 414837 Lot Number: 555011
Distribution pattern: Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Derived failure modes
-
Unknown
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.