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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
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