BEUDAMED
    FDA Enforcement Class II Terminated

    S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.

    Recall: Z-1870-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1870-2013
    Event ID
    65033
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2013
    Initiation Date
    April 25, 2013
    Classification Date
    August 1, 2013
    Termination Date
    January 9, 2014
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.

    Reason

    Malfunction of slap hammer.

    Code Info

    Lot: 56H26

    Distribution

    US distributions to states of: KS and TX.

    Quantity

    3