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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR 3D Knee

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  Class 2 Device Recall EMPOWR 3D Knee see related information
Date Initiated by Firm November 10, 2023
Date Posted December 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0508-2024
Recall Event ID 93465
510(K)Number K171991  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108

DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108

For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Code Information Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Sherri Mellingen
952-913-6383
Manufacturer Reason
for Recall		 Due to incorrect product/device within packaging.
FDA Determined
Cause 2		 Labeling Change Control
Quantity in Commerce 37 devices
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = Encore Medical, L.P.
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