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Terminated

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.

FDA Recall Z-0075-2015 · Posted 2014-10-16

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWT
Date Initiated2014-09-24
Date Terminated2015-07-14
Product Quantity6

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.

Firm Action

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letters dated September 24, 2014, via FedEx overnight to affected customers. The notification included a description of the reason for recall, instructions for responding to the formal recall notification, and affected product, actions to be taken. For questions call (574) 372-1570.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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