Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. ...
FDA Device Recall #Z-2744-2015 — Class II — August 5, 2015
Recall Summary
| Recall Number | Z-2744-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 5, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet Spine, LLC |
| Location | Broomfield, CO |
| Product Type | Devices |
| Quantity | 7 parts |
Product Description
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Reason for Recall
Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
Distribution Pattern
Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
Lot / Code Information
Model Number 14-521614B, lot number 375440.
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-2759-2015 | Class II | Biomet Spine Lineum OCC Starter Flexible and Li... | Jul 22, 2015 |
| Z-2152-2015 | Class II | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Clo... | Mar 12, 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.