FDA recall Z-0126-2023

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-08-12

Report date

2022-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2023