The Recall Desk
HighFDA (Devices)·Z-0075-2015·Announced 2014-10-22

Biomet Recalls Discovery Elbow Humeral Trial Due to Incorrect Etching

Biomet is recalling six Discovery Elbow Humeral Trials that were incorrectly manufactured as left-sided but etched as right-sided.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a manufacturing error could lead to the implantation of the wrong side of a prosthesis, representing a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Biomet, Inc. is recalling six units of the Discovery Elbow Humeral Trial. The recall was initiated after an investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.

The affected units are identified by Catalog Number 414837 and Lot Number 555011. These products were distributed worldwide, including in the United States (specifically in South Dakota, Ohio, and Connecticut) and in The Netherlands and India.

Healthcare providers and facilities should stop using the affected units and contact Biomet for instructions on how to return or dispose of the product. The incorrect etching could lead to the implantation of the wrong side of the prosthesis during surgery.

The recalled product

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
Manufacturer
Biomet, Inc.
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Number: 414837 Lot Number: 555011

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: