Exactech, Inc. recalls Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervic…

Recall date

May 21, 2015

Source

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

Recall number

Z-2070-2015

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Nationwide Distribution to Florida only.

Why it was recalled

Shipped to a single consignee prior to completion of final inspection.

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

What was recalled

Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.