Date Initiated by Firm |
July 06, 2011 |
Date Posted |
August 04, 2011 |
Recall Status1 |
Terminated 3 on September 26, 2012 |
Recall Number |
Z-2945-2011 |
Recall Event ID |
59058 |
510(K)Number |
K023546
|
Product Classification |
Knee Prosthesis, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
Product |
Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc.
A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
|
Code Information |
Part # 183132. Lot # 947480. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact |
Biomet Customer Service 574-267-6639 Ext. 1676
|
Manufacturer Reason for Recall |
The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
|
FDA Determined Cause 2 |
Employee error |
Action |
Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers.
The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form.
For information or questions on this recall call Biomet at (574) 371-3756. |
Quantity in Commerce |
8 |
Distribution |
Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands. |
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 and Original Applicant = BIOMET, INC.
|