Ebi, Llc recalls Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instrument

Recalled January 14, 2015 · FDA recall Z-0909-2015 · Ebi

Hazard

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. · FDA Class II

Units

2816 approx.units ( 2688 units US and 128 OUS)

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Ebi, Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →