Bradshaw Medical Inc. recalls Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reu…

Recall date

February 2, 2015

Source

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

Recall number

Z-1637-2016

FDA classification

Class II

Brand / firm

Bradshaw Medical Inc.

Sold / distributed

US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM

Why it was recalled

A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.

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

What was recalled

Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.