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.
Reported: October 22, 2014 Initiated: September 24, 2014 #Z-0075-2015
Product Description
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.
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.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 6
- Distribution
- Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 6.
Why was this product recalled? ▼
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0075-2015.
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