BEUDAMED
    FDA Enforcement Class II Terminated

    StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.

    Recall: Z-2187-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2187-2013
    Event ID
    65968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spine Wave, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 18, 2013
    Initiation Date
    May 14, 2013
    Classification Date
    September 11, 2013
    Termination Date
    February 10, 2014
    Address
    3 Enterprise Dr Ste 302, N/A, Shelton, CT, 06484-4694, United States

    Description

    StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.

    Reason

    A component Superior endplate manufactured from a different polymer than specified

    Code Info

    Lot Numbers: 272L08 and 272L09

    Distribution

    Distributed in the states of FL and OR.

    Quantity

    17 units