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Open, Classified

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

FDA Recall Z-0126-2023 · Posted 2022-10-21

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2022-08-12
Product Quantity18

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.

Firm Action

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: [email protected]

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

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

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