Encore Medical, LP: Device Recall

Recall #Z-2126-2025 · 06/02/2025

Class II: Risk

Recall Details

Recall Number: Z-2126-2025
Classification: Class II
Product Type: Device
Recalling Firm: Encore Medical, LP
Status: Ongoing
Date Initiated: 06/02/2025
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20

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.

Product Description

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Distribution Pattern

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

Other Recalls by Encore Medical, LP

Class II: Risk 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

View all recalls by Encore Medical, LP →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.