Date Initiated by Firm |
November 13, 2006 |
Date Posted |
December 08, 2007 |
Recall Status1 |
Terminated 3 on December 13, 2007 |
Recall Number |
Z-0361-2008 |
Recall Event ID |
45480 |
510(K)Number |
K022204
|
Product Classification |
Tibia Insert - Product Code JWH
|
Product |
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 |
Code Information |
Model Number: 0214612, Lot Number: 044159 No serial numbers |
Recalling Firm/ Manufacturer |
Plus Orthopedics USA 10188 Telesis Ct San Diego CA 92121-4779
|
For Additional Information Contact |
Clint Corona 888-741-7587 Ext. 2511
|
Manufacturer Reason for Recall |
Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
|
FDA Determined Cause 2 |
Employee error |
Action |
Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices. |
Quantity in Commerce |
10 |
Distribution |
Nationwide: USA including states of ID, NY, VA & WI |
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 = PLUS ORTHOPEDICS
|