FDA Device recall Z-1637-2016
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instr…
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instr… by Bradshaw Medical, citing A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1637-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-02 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bradshaw Medical |
| Distribution | US |
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.
Identifiers
| code_info | Part Number BMI # Customer Lot Code 11-5000-018 512833 102551 512835 102848…Part Number BMI # Customer Lot Code 11-5000-018 512833 102551 512835 102848 527192 OP-CS-I-0026 TO 0046 550398 OP-CS-I-0223 TO 0232 561041 561041-001 TO -030 6200-1109 513884 2009300543 514227 2009300643 514228 2009300743 514229 2009300843 514230 2009300993 516828 2009411377 518909 2010082257 519942 2010152571 522701 2010373025-2010373174 14-525035-00 538133 538133 001-030 538134 538134 001-015 548080 548080 001-015 550475 550475 001-015 552169 552169 001-020 553131 553131 001-015 553710 553710 001-015 558873 558873 001-010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.