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U.S. Department of Health and Human Services

Class 3 Device Recall VKS Knee System

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  Class 3 Device Recall VKS Knee System see related information
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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