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U.S. Department of Health and Human Services

Class 2 Device Recall TCPLUS Solution

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  Class 2 Device Recall TCPLUS Solution see related information
Date Initiated by Firm August 03, 2005
Date Posted October 07, 2005
Recall Status1 Terminated 3 on June 16, 2006
Recall Number Z-0014-06
Recall Event ID 32882
510(K)Number k000666  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product TC-PLUS Tibial Insert 2; 15mm, Model 25309
Code Information Lot code: 0303.13.1623
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		 Did not meet specifications.
FDA Determined
Cause 2		 Other
Action Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.
Quantity in Commerce 21
Distribution Arizona, California, Idaho, New York, Texas, and Virginia
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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