Axial Torque Limiting Driver — Class II medical device recall Z-1637-2016
Terminated recall by Bradshaw Medical Inc., reported 2016-05-18, distributed nationwide. A component failure could cause a situation where the applied torque was significantly higher than the calibra
| Recall number | Z-1637-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bradshaw Medical Inc., Kenosha, WI, United States |
| Recall initiated | 2015-02-02 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2020-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 3,760 units |
| Lot numbers | 001-002, 001-010, 001-015, 001-020, 001-030, 0046, 0232, 030, 102551, 102848, 11-5000-018, 14-525035-00, 1525-10-1, 2009300543, 2009300643, 2009300743, 2009300843, 2009300993, 2009411377, 2010082257, 2010152571, 2010373025-2010373174, 351400, 512833, 512835, 513884, 514227, 514228, 514229, 514230, 516828, 518909, 519942, 522701, 527192, 530249, 538133, 538134, 548080, 550398 and 15 more |
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 for recall
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1637-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.