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U.S. Department of Health and Human Services

Class 2 Device Recall 3DKnee e Tibial Insert

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  Class 2 Device Recall 3DKnee e Tibial Insert see related information
Date Initiated by Firm August 09, 2012
Date Posted August 30, 2012
Recall Status1 Terminated 3 on January 25, 2013
Recall Number Z-2302-2012
Recall Event ID 62801
510(K)Number K091956  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
Product 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm.

The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Code Information Model Number 392-09-706, Lot Number 59602519
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact Teffany Hutto
512-832-9500
Manufacturer Reason
for Recall		 The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.
Quantity in Commerce 7 units
Distribution Worldwide Distribution including Venezuela.
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 = OIY and Original Applicant = ENCORE MEDICAL, L.P.
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