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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Bradshaw Medical Inc.
- 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
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