BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2070-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2070-2015
    Event ID
    71501
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 22, 2015
    Initiation Date
    May 21, 2015
    Classification Date
    July 14, 2015
    Termination Date
    July 16, 2015
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    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.

    Reason

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

    Code Info

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

    Distribution

    Nationwide Distribution to Florida only.

    Quantity

    4 devices.