FDAFDA · Food and drugs·Recall number Z-0075-2015
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.
Published October 22, 2014 · Recall initiated: September 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
- Lot
- Catalog Number: 414837 Lot Number: 555011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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