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U.S. Department of Health and Human Services

Class 2 Device Recall 3D Knee Tibial InsertDCM

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 Class 2 Device Recall 3D Knee Tibial InsertDCMsee related information
Date Initiated by FirmMarch 19, 2010
Date PostedApril 26, 2010
Recall Status1 Terminated 3 on July 22, 2010
Recall NumberZ-1433-2010
Recall Event ID 55171
510(K)NumberK020114 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
Code Information Catalog Number: 392-11-604, Lot Number: 59600085.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		Affected product had incorrect color label which is a secondary visual indicator for sizing.
FDA Determined
Cause 2		Packaging process control
ActionEncore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.
Quantity in Commerce7 units
DistributionWorldwide Distribution -- United States (UT, IA) and Germany.
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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