Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 18, 2016
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.
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Bradshaw Medical Inc. recalled Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axi… - a moderate-severity action.
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axi… was recalled by Bradshaw Medical Inc. in May 18, 2016. Reason: A component failure could cause a situation where the applied torque was significantly higher than the calibr…. Check the official notice for the remedy. Verify recall #Z-1637-2016 with the FDA Devices before acting.
The recall
Bradshaw Medical Inc. issued this moderate-severity FDA Devices recall-A component failure could cause a situation where the applied torque was significantly higher than the calibr….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- May 18, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1637-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1637-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on February 2, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bradshaw Medical Inc. is listed as the recalling firm, operating out of Kenosha, WI. Federal records list the affected scope as 3,760 units.
The documented reason for this recall is: A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,760 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1637-2016 |
| Date reported | May 18, 2016 |
| Date initiated | February 2, 2015 |
| Recalling firm | Bradshaw Medical Inc. |
| Firm location | Kenosha, WI |
| Affected scope | 3,760 units |
| Distribution | US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1637-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bradshaw Medical Inc.. Units affected: 3,760 units.
Why was this product recalled? ▼
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1637-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1637-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 18, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.