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U.S. Department of Health and Human Services

Class 2 Device Recall DJO EMPOWR KNEE Femoral Sizer

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  Class 2 Device Recall DJO EMPOWR KNEE Femoral Sizer see related information
Date Initiated by Firm February 05, 2021
Create Date April 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-1524-2021
Recall Event ID 87332
510(K)Number K143242  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product DJO EMPOWR KNEE Femoral Sizer
Code Information Model Number: 800-05-034 Lot Number: 326336L02
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Christine Chesnutt
512-834-6207
Manufacturer Reason
for Recall		 Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 02/05/2021, the firm sent an "URGENT FIELD SAFETY NOTICE" Recall letter to customers via e-mail informing them that a product complaint was received where a subcomponent of the sizer was assembled incorrectly. As a result, the windows provided to show the size are facing the opposite direction. When the sizer is in place, the size read from the distal facing side of the instrument is obscured. The risks associated with this issue include: -Delay in surgery -Revision surgery Customers are instructed to the below actions by February 26, 2021: 1. This notice needs to be passed on to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. Customers will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Any questions or assistance - contact the Manager, Regulatory Affairs at e-mail teffany.hutto@djoglobal.com
Quantity in Commerce 16 units
Distribution U.S.: FL, IN, and MN O.U.S.: None
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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