Z-0075-2015 Class II Terminated
FDA device recall Z-0075-2015 was initiated by Biomet, Inc. on Sep 24, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 22, 2014
- Initiation Date
- Sep 24, 2014
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Code Information
Catalog Number: 414837 Lot Number: 555011
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0075-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026