BEUDAMED
    FDA Enforcement Class I Terminated

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    Recall: Z-2118-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2118-2017
    Event ID
    77089
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    EBI Patient Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    April 20, 2017
    Classification Date
    May 25, 2017
    Termination Date
    October 17, 2018
    Address
    484 Calle E, Guaynabo, PR, 00969-3454, United States

    Description

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    Reason

    Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

    Code Info

    Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.

    Distribution

    Nationwide distribution only.

    Quantity

    33 units total