BEUDAMED
    FDA Enforcement Class II Terminated

    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

    Recall: Z-1480-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1480-2015
    Event ID
    70710
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Captiva Spine, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    February 25, 2015
    Classification Date
    April 21, 2015
    Termination Date
    June 1, 2015
    Address
    967 Alternate A1A, Suite1, Jupiter, FL, 33477, United States

    Description

    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).

    Reason

    It is possible for the titanium color-coded ring to detach from the Reamers.

    Code Info

    Part #: PI-0507, Lot #s:1308811A, 1457704A; Part #: PI-0508, Lot #s: 1308812A, 1457705A; Part #: PI-0509, Lot #s: 1038813A, 1457706A; Part #: PI-0510, Lot #s: 1308814A, 1457707A; Part #: PI-0511, Lot #s: 1308815A, 1457708A; Part #: PI-0512, Lot #s: 1308816A, 1457709A; Part #: PI-0513, Lot #s: 1308817A, 1457710A; Part #: PI-0514, Lot #s: 1308818A, 1457711A; Part #: PI-0507-S, Lot #: 2130005; Part #: PI-0508-S, Lot #: 2130006; Part #: PI-0509-S, Lot #: 2130007; Part #: PI-0510-S, Lot #: 2130008; Part #: PI-0511-S, Lot #: 2130009; Part #: PI-0512-S, Lot #: 2130010; Part #: PI-0513-S, Lot #:2130011; Part #: PI-0514-S, Lot #: 2130012

    Distribution

    GA, IN, FL, UT, AZ, CA, and NY

    Quantity

    233 devices