Recall Z-0700-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems 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.
| Date | Jan 11, 2012 (initiated Oct 4, 2011) |
| Status | Terminated |
| Reason | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 149 |
| Distribution | Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040770 | VANGUARD PATELLA COMPONENTS Biomet Manufacturing, Inc., Apr 22, 2004 |