FDA-Device2014-10-22Class II
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.
Biomet, Inc.
Hazard
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Sold states
Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Affected count
6
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0075-2015Don't want to check this manually?
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