Date Initiated by Firm |
December 02, 2005 |
Date Posted |
January 18, 2006 |
Recall Status1 |
Terminated 3 on January 29, 2007 |
Recall Number |
Z-0397-06 |
Recall Event ID |
34255 |
510(K)Number |
K022204
|
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
Product |
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) |
Code Information |
PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII |
Recalling Firm/ Manufacturer |
Plus Orthopedics USA 10188 Telesis Ct San Diego CA 92121-4779
|
For Additional Information Contact |
Natalie J. Kennel 888-741-7587 Ext. 2526
|
Manufacturer Reason for Recall |
The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
|
FDA Determined Cause 2 |
Other |
Action |
The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification. |
Quantity in Commerce |
14 |
Distribution |
Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin |
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
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