Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides poste...
FDA Device Recall #Z-1466-2015 — Class II — March 12, 2015
Recall Summary
| Recall Number | Z-1466-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 12, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet Spine, LLC |
| Location | Broomfield, CO |
| Product Type | Devices |
| Quantity | 874 |
Product Description
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Reason for Recall
Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
538133,538134,548080,550475,552169,553131,553710,558873,567568,569141 Part Number: 6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174
Other Recalls from Biomet Spine, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1253-2016 | Class II | 10mm X 12o Solitaire Ti Medium Spacer Solitai... | Feb 12, 2016 |
| Z-0203-2016 | Class II | MaxAn 4.0mm and 4.5mm fixed screws, used in the... | Sep 29, 2015 |
| Z-2744-2015 | Class II | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable ... | Aug 5, 2015 |
| Z-2759-2015 | Class II | Biomet Spine Lineum OCC Starter Flexible and Li... | Jul 22, 2015 |
| Z-1465-2015 | Class II | Lineum HF Torque Handle Limit (Lineum) Model Nu... | Mar 12, 2015 |
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.