Amendia, Inc recalls Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated…

Recall date

November 22, 2016

Source

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

Recall number

Z-0966-2017

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

US Distribution to GA only.

Why it was recalled

Absent tantalum market pin.

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

What was recalled

Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.