Class II recallOngoing

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

FDA · FDA event 98700 · Posted Jul 8, 2026

Published Jul 8, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Due to packaging discrepancy with incorrect product size mixed up.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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 productsafety@enovis.com

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists EMPOWR 3D KNEE INS, 11L 14MM, VE by Encore Medical, LP.

Products affected by FDA event 98700
Model	Description	Lot / serial range	Manufactured	Status
Z-2701-2026 · 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.	EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.	Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)	Not provided in the normalized record	Ongoing
Z-2700-2026 · 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.	EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.	Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026	Not provided in the normalized record	Ongoing

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
Units affected: See official FDA record
Category: Knee implants

Timeline

Feb 16, 2026
Recall initiated
Date recorded by the FDA.
Jul 8, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98700
Published: Jul 8, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

FDA · FDA event 98700 · Posted Jul 8, 2026

Published Jul 8, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists EMPOWR 3D KNEE INS, 11L 14MM, VE by Encore Medical, LP.

Products affected by FDA event 98700
Model	Description	Lot / serial range	Manufactured	Status
Z-2701-2026 · 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.	EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.	Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)	Not provided in the normalized record	Ongoing
Z-2700-2026 · 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.	EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.	Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026	Not provided in the normalized record	Ongoing

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

Units affected

See official FDA record

Persona Revision Trabecular Metal Femoral Distal Augment recall — FDA event 99073

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

FDA · FDA event 99073Posted Jun 24, 2026

Class II recallOngoing

TRI TS BASEPLATE SIZE 3 recall — FDA event 99080

FDA · FDA event 99080Posted Jun 17, 2026

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Endo-Model SL Connection Component incl recall — FDA event 98342

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

FDA · FDA event 98342Posted Mar 10, 2026

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Follow EMPOWR 3D KNEE INS, 11L 14MM, VE

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

EMPOWR 3D KNEE INS, 11L 14MM, VE recall — FDA event 98700

Follow EMPOWR 3D KNEE INS, 11L 14MM, VE

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline