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

Recall date

October 8, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0909-2015

FDA classification

Class II

Brand / firm

Ebi, Llc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.