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U.S. Department of Health and Human Services

Class 2 Device Recall 3DKNEE Tibial Insert Trial

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 Class 2 Recall
3DKNEE Tibial Insert Trial
see related information
Date Posted August 20, 2008
Recall Status1 Terminated on September 02, 2008
Recall Number Z-1539-2008
Recall Event ID 46960
Premarket Notification
510(K) Number
K020114 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
Code Information Lot #53906407
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Manufacturer Reason
for Recall
Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
Quantity in Commerce 6 units.
Distribution Distribution --- country of Germany.
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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