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

Recall Initiated

August 12, 2022

Posted

October 21, 2022

Recall Number

Z-0126-2023

Quantity

18

Firm Location

Austin, TX

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

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

Lot / Code Info

UDI-DI/Lot: 00888912167055/132T1085

Root Cause

Process control

Action Taken

On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: Julie.Baker@Enovis.com