Recall Z-0474-2013
Biomet, Inc. · initiated November 1, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog Number: 113740 and Lot Number Identification: 779270
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.
FDA-determined cause: Process control
Action taken
Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
Details
- Recall number
- Z-0474-2013
- Initiated
- November 1, 2012
- Posted by FDA
- December 5, 2012
- Terminated
- August 29, 2013
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Quantity
- 4
- Distribution
- USA Nationwide Distribution in the state of WI.
- Recalling firm
- Biomet, Inc., Warsaw, IN