Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050...
FDA Device Recall #Z-2759-2015 — Class II — July 22, 2015
Recall Summary
| Recall Number | Z-2759-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 22, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet Spine, LLC |
| Location | Broomfield, CO |
| Product Type | Devices |
| Quantity | 49 |
Product Description
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
Reason for Recall
Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Distribution Pattern
Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
Lot / Code Information
P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
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-2152-2015 | Class II | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Clo... | Mar 12, 2015 |
| Z-1466-2015 | Class II | Torque Limiting Handle (Aspen/ Alpine) 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.