Encore Medical, LP: Device Recall

Recall #Z-0766-2025 · 12/18/2024

Class II: Risk

Recall Details

Recall Number: Z-0766-2025
Classification: Class II
Product Type: Device
Recalling Firm: Encore Medical, LP
Status: Ongoing
Date Initiated: 12/18/2024
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 33

Reason for Recall

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

Product Description

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Distribution Pattern

US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, 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.