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.
Enforcement
- Recall Number
- Z-0909-2015
- Event ID
- 69785
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ebi, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2015
- Initiation Date
- October 8, 2014
- Classification Date
- January 5, 2015
- Termination Date
- December 21, 2015
- Address
- 399 Jefferson Rd, N/A, Parsippany, NJ, 07054-3707, United States
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.
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.
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
Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
2816 approx.units ( 2688 units US and 128 OUS)