Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set scre...

FDA Device Recall #Z-0909-2015 — Class II — October 8, 2014

Recall Summary

Recall Number Z-0909-2015
Classification Class II — Moderate risk
Date Initiated October 8, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ebi, Llc
Location Parsippany, NJ
Product Type Devices
Quantity 2816 approx.units ( 2688 units US and 128 OUS)

Product Description

Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.

Reason for Recall

Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.

Distribution Pattern

Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.

Lot / Code Information

Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS

Other Recalls from Ebi, Llc

Recall # Classification Product Date
Z-1619-2024 Class II 48" Lead Wires, Replacement Part Number: 10677... Mar 22, 2024
Z-1618-2024 Class II 20" Lead Wires, Replacement Part Number: 10677... Mar 22, 2024
Z-1616-2024 Class II Biomet SpinalPak Non-invasive Spine Fusion Stim... Mar 22, 2024
Z-1617-2024 Class II Biomet OrthoPak Non-invasive Bone Growth Stimul... Mar 22, 2024
Z-0874-2015 Class II Solitaire-C Cervical Spacer System a) 14-531... Nov 11, 2014

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.