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U.S. Department of Health and Human Services

Class 2 Device Recall VKS PE

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 Class 2 Recall
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Date Posted December 08, 2007
Recall Status1 Terminated on December 13, 2007
Recall Number Z-0361-2008
Recall Event ID 45480
Premarket Notification
510(K) Number
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - 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/
Plus Orthopedics USA
10188 Telesis Ct
San Diego, California 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
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = PLUS ORTHOPEDICS