Z-0474-2013 Class II Terminated
FDA device recall Z-0474-2013 was initiated by Biomet, Inc. on Nov 1, 2012 and is designated Class II. Reason for recall: The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly… The recall status is terminated (terminated Aug 29, 2013). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2012
- Initiation Date
- Nov 1, 2012
- Termination Date
- Aug 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Reason for Recall
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Distribution Pattern
USA Nationwide Distribution in the state of WI.
Code Information
Catalog Number: 113740 and Lot Number Identification: 779270
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0474-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026