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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR 3D Kneetm INS

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  Class 2 Device Recall EMPOWR 3D Kneetm INS see related information
Date Initiated by Firm May 05, 2022
Create Date June 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1257-2022
Recall Event ID 90230
510(K)Number K143242  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Code Information Lot number 078T1141
Recalling Firm/
Manufacturer
Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
FDA Determined
Cause 2
Labeling mix-ups
Action On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.
Quantity in Commerce 20
Distribution U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
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 = JWH and Original Applicant = ENCORE MEDICAL, L.P.
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