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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Insert

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  Class 2 Device Recall Tibial Insert see related information
Date Initiated by Firm April 01, 2013
Date Posted May 02, 2013
Recall Status1 Terminated 3 on July 01, 2013
Recall Number Z-1213-2013
Recall Event ID 64859
510(K)Number K091956  
Product Classification prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
Product 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Code Information Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact Teffany Hutto
Manufacturer Reason
for Recall
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
FDA Determined
Cause 2
Labeling mix-ups
Action The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.
Quantity in Commerce 5
Distribution US Distribution to the state of California and International Distribution to the country of 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.