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Bradshaw Medical Inc. recalls Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a
Recalled May 18, 2016 · FDA recall Z-1637-2016 · Bradshaw Medical
Hazard
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. · FDA Class II
Units
3,760 units
Sold at
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
Description
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Product
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.
Manufacturer(s)
Bradshaw Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →