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

Recalled July 22, 2015 · FDA recall Z-2070-2015 · Exactech

Hazard

Shipped to a single consignee prior to completion of final inspection. · FDA Class II

Units

4 devices.

Sold at

Nationwide Distribution to Florida only.

Description

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

Product

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.

Manufacturer(s)

Exactech, Inc.

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