Recall Z-0075-2015— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2014-09-24, terminated 2015-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-24
- Terminated
- 2015-07-14
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.