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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 Device Recall 3DKNEE Tibial Insert Trial see related information
Date Initiated by Firm February 20, 2008
Date Posted August 20, 2008
Recall Status1 Terminated 3 on September 02, 2008
Recall Number Z-1539-2008
Recall Event ID 46960
510(K)Number K020114  
Product Classification Knee Prosthesis - 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 TX 78758
For Additional Information Contact
512-832-9500
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		 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 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 = ENCORE ORTHOPEDICS, INC.
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