Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-3...
FDA Device Recall #Z-0380-2013 — Class II — August 9, 2012
Recall Summary
| Recall Number | Z-0380-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 9, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Spine |
| Location | Allendale, NJ |
| Product Type | Devices |
| Quantity | 54 |
Product Description
Stryker XIA 3 TORQUE WRENCH REF 48237028 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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Lot / Code Information
Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
Other Recalls from Stryker Spine
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1489-2025 | Class II | Monterey AL Implant Inserter; 14/16mm; Catalog ... | Feb 28, 2025 |
| Z-1490-2025 | Class II | Monterey AL Implant Inserter; 18/20mm; Catalog ... | Feb 28, 2025 |
| Z-1491-2025 | Class II | Monterey AL Implant Inserter; 22mm; Catalog 480... | Feb 28, 2025 |
| Z-1488-2025 | Class II | Monterey AL Implant Inserter; 10/12mm; Catalog ... | Feb 28, 2025 |
| Z-3210-2024 | Class II | AVS Anchor-C Cervical Cage System Instructions ... | Aug 23, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.