Z-0126-2023 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type
Devices
Report Date
November 2, 2022
Initiation Date
August 12, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18

Product Description

EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.

Reason for Recall

Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

Distribution Pattern

US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.

Code Information

UDI-DI/Lot: 00888912167055/132T1085