| Class 2 Device Recall Biomet Series A Standard Patella size 25mm, three pegs 184760 | |
Date Initiated by Firm | October 04, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on April 08, 2013 |
Recall Number | Z-0700-2012 |
Recall Event ID |
60144 |
510(K)Number | K040770 |
Product Classification |
Prothesis, knee,patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | 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. |
Code Information |
Part 184760, Lot 190410, 369920, 423430, 572150, 633870, 721650. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | Mary Hardesty 574-371-3755 |
Manufacturer Reason for Recall | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JWH
|
|
|
|