PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 2, 2022 Initiated: August 12, 2022 #Z-0126-2023

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.

Details

Recalling Firm
Encore Medical, LP
Units Affected
18
Distribution
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Location
Austin, TX

Frequently Asked Questions

What product was recalled?
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.. Recalled by Encore Medical, LP. Units affected: 18.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0126-2023.