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.
Recall
- Recall Number
- Z-0909-2015
- Event Number
- 69785
- Firm
- Ebi, Llc
- FEI Number
- 2242816
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 8, 2014
- Posted
- January 5, 2015
- Terminated
- December 21, 2015
- Address
- 399 Jefferson Rd, Parsippany, NJ, 07054-3707
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.
The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter. If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548.
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)