BEUDAMED
    FDA Enforcement Class II Terminated

    LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.

    Recall: Z-0220-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0220-2015
    Event ID
    69615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 26, 2014
    Initiation Date
    March 9, 2011
    Classification Date
    November 14, 2014
    Termination Date
    January 7, 2015
    Address
    310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, 80021-3464, United States

    Description

    LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.

    Reason

    Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

    Code Info

    Lot numbers L532655, L532690, Product code 8503XXXX

    Distribution

    US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,

    Quantity

    120