Discovery Elbow Humeral Trial (Biomet) – Incorrect Marking (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Catalog Number: 414837 Lot Number: 555011
Products Sold
Catalog Number: 414837 Lot Number: 555011
Biomet, Inc. is recalling Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint repla due to An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026