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U.S. Department of Health and Human Services

Class 2 Device Recall VKS Tibial Trial

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 Class 2 Recall
VKS Tibial Trial
see related information
Date Posted December 08, 2007
Recall Status1 Terminated on December 13, 2007
Recall Number Z-0362-2008
Recall Event ID 45484
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics
Code Information Model Numbers/Lot Codes: 1214331/EM.1 and EM.6, 1214332/EM.1 and EM.6, 1214333/EM.1, 1214334/EM.5, and 1214335/EM.1
Recalling Firm/
Manufacturer
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
The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used.
Quantity in Commerce 19
Distribution Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA
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.
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