Recall Z-1637-2016— Bradshaw Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Bradshaw Medical Inc., initiated 2015-02-02, terminated 2020-01-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting..
- Recalling firm
- Bradshaw Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-02
- Terminated
- 2020-01-10
- Firm location
- Kenosha, WI, United States
Product description
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.
Reason for recall
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Data sourced from openFDA. This site is unofficial and independent of the FDA.