Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number:

FDA device recall Z-2126-2025 · posted 2025-07-17 · Open, Classified

Recall details

Recalling firm

Encore Medical, LP

Reason for recall

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

Action taken

On 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This 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 their regional email address, to place a replacement request. They will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. Any questions, contact Recall Coordinator at productsafety@enovis.com or call/text 682-299-9133.

Root cause

Packaging change control

Status

Open, Classified

Product code

JWH

Quantity affected

20

Distribution

U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

Date initiated

2025-06-02

Date posted

2025-07-17

Location

Austin, TX

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