Drug recall
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver…
FDA recall event 73873 · Class II · Bradshaw Medical Inc.
Key facts
| Event ID | 73873 |
|---|---|
| Recall numbers | Z-1637-2016 |
| Recalling firm | Bradshaw Medical Inc. |
| Product type | Devices |
| 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)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. |
| Initiation date | Feb 2, 2015 |
| Report date | May 18, 2016 |
| Termination date | Jan 10, 2020 |
| City | Kenosha |
| State | WI |
| Country | United States |
| FEI number | 3006846753 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: