Exactech, Inc. recalls Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3

Recalled March 26, 2014 · FDA recall Z-1217-2014 · Exactech

Hazard

The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy. · FDA Class II

Units

242

Sold at

USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.

Description

The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.

Product

Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.

Manufacturer(s)

Exactech, Inc.

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