BEUDAMED
    FDA Recall 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 · Initiated March 9, 2011

    Recall

    Recall Number
    Z-0220-2015
    Event Number
    69615
    Firm
    Biomet Spine LLC.
    FEI Number
    3012447612
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 9, 2011
    Posted
    December 16, 2014
    Terminated
    January 7, 2015
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    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.

    Action

    Biomet notified customers by phone on March 9, 2011 to return the affected product.

    Distribution

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

    Quantity

    120