Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle ...
FDA Device Recall #Z-2318-2017 — Class II — May 10, 2017
Recall Summary
| Recall Number | Z-2318-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 10, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Biomet Spine Inc. |
| Location | Westminster, CO |
| Product Type | Devices |
| Quantity | 497 units |
Product Description
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
Reason for Recall
Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
Distribution Pattern
Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
Lot / Code Information
Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
Other Recalls from Zimmer Biomet Spine Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0639-2024 | Class II | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.... | Oct 16, 2023 |
| Z-0868-2019 | Class II | Vitality¿ Spinal Fixation System.Spinal Interve... | Jul 30, 2018 |
| Z-0866-2019 | Class II | Vitality¿ Spinal Fixation System. Thoracolumbos... | Jul 30, 2018 |
| Z-0867-2019 | Class II | Vitality¿ Spinal Fixation System. Spinal Interl... | Jul 30, 2018 |
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.