Ebi, Llc recalls Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixatio

Recalled September 25, 2013 · FDA recall Z-2214-2013 · Ebi

Hazard

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. · FDA Class II

Units

427 units

Sold at

Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.

Description

Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.

Product

Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

Manufacturer(s)

Ebi, Llc

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