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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR PS KNEE(TM) e

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  Class 2 Device Recall EMPOWR PS KNEE(TM) e see related information
Date Initiated by Firm September 15, 2017
Create Date October 20, 2017
Recall Status1 Terminated 3 on August 29, 2023
Recall Number Z-0041-2018
Recall Event ID 78193
510(K)Number K160342  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE


Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Code Information Lot Number 287U1004
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
FDA Determined
Cause 2		 Packaging process control
Action The firm initiated the recall by email on 09/05/2017. The letter identified the affected product, problem and actions to be taken. The consignee was directed to notify anyone to whom the product was transferred and to return any in-stock product.
Quantity in Commerce 48 units
Distribution US Nationwide Distribution
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.
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