Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2012
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Spine recalled Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I M… - a moderate-severity action.
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I M… was recalled by Stryker Spine in November 28, 2012. Reason: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.. Check the official notice for the remedy. Verify recall #Z-0381-2013 with the FDA Devices before acting.
The recall
Stryker Spine issued this moderate-severity FDA Devices recall-Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening..
- Moderate
- severity level
- 19 units
- affected scope
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0381-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0381-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on August 9, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Spine is listed as the recalling firm, operating out of Allendale, NJ. Federal records list the affected scope as 19 units.
The documented reason for this recall is: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the 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
19 units
Related Recalls
6
3 from same agency
Product description
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
Reason for recall
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0381-2013 |
| Date reported | November 28, 2012 |
| Date initiated | August 9, 2012 |
| Recalling firm | Stryker Spine |
| Firm location | Allendale, NJ |
| Affected scope | 19 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the 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-0381-2013) 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? ▼
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.. Recalled by Stryker Spine. Units affected: 19 units.
Why was this product recalled? ▼
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0381-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0381-2013) 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 November 28, 2012. 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.