BEUDAMED
    FDA Enforcement Class III Terminated

    Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    Recall: Z-1266-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1266-2013
    Event ID
    53487
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spinal Elements, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    April 17, 2009
    Classification Date
    May 7, 2013
    Termination Date
    May 7, 2013
    Address
    3115 Melrose Dr, Suite 200, Carlsbad, CA, 92010-6690, United States

    Description

    Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    Reason

    Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

    Code Info

    Lot Number: 080602

    Distribution

    Distributed in OH and PA.

    Quantity

    68 units total