Recall record at a glance
| Official record | Z-1637-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Bradshaw Medical Inc. |
| Report date | May 18, 2016 |
| Recall initiation date | Feb 2, 2015 |
| Quantity | 3,760 units |
| Location | Kenosha, WI, United States |
Official 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.
Why the product was recalled
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Distribution information
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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