Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Descr

FDA device recall Z-2700-2026 · posted 2026-07-08 · Open, Classified

Recall details

Recalling firm

Encore Medical, LP

Reason for recall

Due to packaging discrepancy with incorrect product size mixed up.

Action taken

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

Root cause

Process change control

Status

Open, Classified

Product code

JWH

Quantity affected

4

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

Date initiated

2026-02-16

Date posted

2026-07-08

Location

Austin, TX

Related 510(k) clearances