Class II — Bradshaw Medical Inc.
| Recalling firm | Bradshaw Medical Inc. |
|---|---|
| Registered facility | Bradshaw Medical Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 3,760 units |
| Distribution | US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM |
| Initiated | 2015-02-02 |
| Classified | 2016-05-10 |
| Terminated | 2020-01-10 |
| Recall number | Z-1637-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bradshaw Medical Inc. (Z-1637-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73873/
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