United Orthopedic Corporation recalls UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery…

Recall date

February 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1692-2017

FDA classification

Class II

Brand / firm

United Orthopedic Corporation

Sold / distributed

Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.

Why it was recalled

The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.