The Recall Desk
SevereFDA (Devices)·Z-1637-2016·Announced 2016-05-18

Bradshaw Medical Recalls Axial Torque Limiting Drivers Due to Component Failure

Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a medical device where a component failure could lead to significant deviation from calibrated safety settings (potentially causing injury during surgery) is categorized as Severe (Score 4), as it represents a significant risk of harm even if specific injury reports are not detailed in the provided text snippet.

Plain-English summary

Bradshaw Medical Inc. is recalling 3,760 units of the Axial Torque Limiting Driver (1st generation). This reusable surgical instrument is designed to limit the magnitude of applied torque transferred to an external device or fastener. The recall is being conducted because a component failure could cause the applied torque to be significantly higher than the calibrated torque setting.

The affected products were distributed nationwide in the United States, specifically in California, Florida, Indiana, Massachusetts, Michigan, Ohio, Pennsylvania, Tennessee, Utah, and Virginia, as well as in the United Kingdom. The recall covers specific part numbers and customer lot codes listed in the official FDA notice.

Healthcare facilities and users of these devices should stop using the affected Axial Torque Limiting Drivers immediately. Users should contact Bradshaw Medical Inc. for instructions on how to return the devices for repair or replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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 d
Manufacturer
Bradshaw Medical Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
3,760

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 006

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same hazard · component failure

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