EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
FDA Recall #Z-0761-2025 — Class II — December 10, 2024
Product Description
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Reason for Recall
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9
Distribution
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Code Information
UDI-DI: 00888912167338. Lot: 076T1273A
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated