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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 FirmDecember 18, 2024
Date PostedDecember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0766-2025
Recall Event ID 96019
510(K)NumberK143242 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductEMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Code Information REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactSherri Mellingen
512-832-9500
Manufacturer Reason
for Recall		5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 12/18/2024, recall notices were emailed to consignees 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. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com If you have questions contact the firm at productsafety@enovis.com
Quantity in Commerce33
DistributionUS Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, 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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