DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Recall Initiated

May 5, 2022

Recall Number

Z-1257-2022

Quantity

20

Firm Location

Austin, TX

Reason for Recall

A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

Distribution

U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.

Lot / Code Info

Lot number 078T1141

Root Cause

Labeling mix-ups

Action Taken

On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.