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.
FDA Recall Z-1637-2016 · Posted 2016-05-10
Recalling FirmBradshaw Medical Inc.
Recall StatusTerminated
Product CodeHXC
Date Initiated2015-02-02
Date Terminated2020-01-10
Product Quantity3,760 units
Reason for Recall
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Firm Action
Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.