FDA-Device2016-05-18Class II
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.
Bradshaw Medical Inc.
Hazard
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Sold states
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
Affected count
3,760 units
Manufactured in
10325 58th Pl, N/A, Kenosha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2016Don't want to check this manually?
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