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Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE… recallZ-2700-2026 · Encore Medical, LP · initiated Feb 16, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to packaging discrepancy with incorrect product size mixed up.

FDA root cause category: Process change control

What the company is doing

On 02/16/2026, the firm emailed an "Urgent: Medical Device Recall" letter to customers informing them that Enovis (Encore Medical L.P) became aware that there is a potential packaging discrepancy with the EMPOWR 3D Knee INS. 342-19-703 (Lot 177T1057), EMPOWR 3D Knee INS, 3R, 19MM, VE, was found within the packaging of a 342-14-711 (Lot 145T1067), EMPOWR 3D Knee INS, 11R, 14MM, VE Customers are instructed to: 1. Review stock for the products and lot numbers for the items to be returned. 2. 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 regional email address, to place a replacement request. An RMA number and shipping label will be provided to return the affected product. 4. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. For any questions, call/text 682-299-9133 or email [email protected]

Recall details

Recall number
Z-2700-2026
Status
Open, Classified
Initiated by the company
Feb 16, 2026
Posted by the FDA
Jul 8, 2026
Recalling firm
Encore Medical, LP
Quantity
4
Product code
JWH
FDA submissions
K143242
Distribution
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 GL108 Great Lakes Medical Illiniois (IL) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 Total 11

Product description

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.

Code information (models, lots, serial numbers)

Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

25 devices cleared under K143242 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98700).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page