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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR 3D KNEE TIBIAL INSERT EPLUS

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 Class 2 Device Recall EMPOWR 3D KNEE TIBIAL INSERT EPLUSsee related information
Date Initiated by FirmJune 02, 2025
Date PostedJuly 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2126-2025
Recall Event ID 97048
510(K)NumberK143242 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
Code Information Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactSherri Mellingen
952-9136383
Manufacturer Reason
for Recall		Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
FDA Determined
Cause 2		Packaging change control
ActionOn 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through their regional email address, to place a replacement request. They will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. Any questions, contact Recall Coordinator at productsafety@enovis.com or call/text 682-299-9133.
Quantity in Commerce20
DistributionU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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