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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-0015-06
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 UC 4; 11mm, Model 25427
Code Information Lot code: 0501.13.0198
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 9
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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