Innovasis, Inc recalls Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide

Recalled February 28, 2018 · FDA recall Z-0644-2018 · Innovasis

Hazard

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. · FDA Class II

Units

1,010 parts

Sold at

United States

Description

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Product

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

Manufacturer(s)

Innovasis, Inc

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