Encore Medical, LP: Device Recall

Recall #Z-0761-2025 · 12/10/2024

Class II: Risk

Recall Details

Recall Number: Z-0761-2025
Classification: Class II
Product Type: Device
Recalling Firm: Encore Medical, LP
Status: Ongoing
Date Initiated: 12/10/2024
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9

Reason for Recall

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

Product Description

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Distribution Pattern

US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, 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.