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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmFebruary 22, 2005
Date PostedNovember 03, 2005
Recall Status1 Terminated 3 on February 05, 2007
Recall NumberZ-0126-06
Recall Event ID 32837
510(K)NumberK000666 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
ProductTC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
Code Information Exp Date of 2011. No serial number. Lot number 0411.13.6556.
Recalling Firm/
Manufacturer		 Plus Orthopedics USA
10188 Telesis Ct
San Diego CA 92121-4779
For Additional Information ContactNatalie J. Kennel
888-741-7587 Ext. 2526
Manufacturer Reason
for Recall		Labeling discrepancy.
FDA Determined
Cause 2		Other
ActionFirm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.
Quantity in Commerce1 unit
DistributionNY
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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