Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
Recall
- Recall Number
- Z-0697-2012
- Event Number
- 60144
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- October 4, 2011
- Posted
- January 11, 2012
- Terminated
- April 8, 2013
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.