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Open, Classified

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

FDA Recall Z-1257-2022 · Posted None

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2022-05-05
Product Quantity20

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.

Firm Action

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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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