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U.S. Department of Health and Human Services

Class 2 Device Recall Total knee implant

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  Class 2 Device Recall Total knee implant see related information
Date Initiated by Firm November 15, 2016
Create Date December 06, 2016
Recall Status1 Terminated 3 on January 20, 2017
Recall Number Z-0711-2017
Recall Event ID 75715
510(K)Number K143242  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Empowr Knee System

Product Usage:
Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Code Information 033T1022
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
Manufacturer Reason
for Recall
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
FDA Determined
Cause 2
Mixed-up of materials/components
Action The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.
Quantity in Commerce 7 units
Distribution US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
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 MEDICAL, L.P.