BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile 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 one level from C2-T1.

    Recall: Z-0455-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0455-2014
    Event ID
    66538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 11, 2013
    Initiation Date
    September 30, 2013
    Classification Date
    December 5, 2013
    Termination Date
    April 16, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile 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 one level from C2-T1.

    Reason

    A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

    Code Info

    part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745

    Distribution

    Nationwide Distribution - only AZ .

    Quantity

    1