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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR 3D Knee Tibial Insert

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 Class 2 Device Recall EMPOWR 3D Knee Tibial Insertsee related information
Date Initiated by FirmJanuary 05, 2026
Date PostedFebruary 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1233-2026
Recall Event ID 98177
510(K)NumberK143242 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductEMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Code Information UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactSherri Mellingen
952-913-6383
Manufacturer Reason
for Recall		942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 1/5/2026, recall notices were emailed to customers who were asked to do the following: 1) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2) Contact the firm to arrange for affected device return. 3. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com Customers with questions can email the firm at productsafety@enovis.com
Quantity in Commerce19
DistributionUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
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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