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

Recall date

January 8, 2018

Source

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

Recall number

Z-0644-2018

FDA classification

Class II

Brand / firm

Innovasis, Inc

Sold / distributed

United States

Why it was recalled

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

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

What was recalled

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: