Exactech, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2070-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 21, 2015

Date Posted: July 22, 2015

Recall Number: Z-2070-2015

Event ID: 71501

Reason for Recall:

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

Status: Terminated

Product Quantity: 4 devices.

Code Information:

Catalog Number 05-100-03-0042, Lot # 68122001.

Distribution Pattern:

Nationwide Distribution to Florida only.

Voluntary or Mandated:

Voluntary: Firm initiated