BEUDAMED
    FDA Recall 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 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-2187-2013
    Event Number
    65968
    Firm
    Spine Wave, Inc.
    FEI Number
    3004638600
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 14, 2013
    Posted
    September 11, 2013
    Terminated
    February 10, 2014
    Address
    3 Enterprise Dr, Ste 302, Shelton, CT, 06484-4694

    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

    Action

    Spine Wave notified surgeons verbally on 5/14/13 and followed by written notification on June 6, 2013 of the incorrect polymer used for the endplate and the health risks.

    Distribution

    Distributed in the states of FL and OR.

    Quantity

    17 units