BEUDAMED
    FDA Recall Terminated

    Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.

    Recall: Z-0932-2013 · Initiated August 24, 2012

    Recall

    Recall Number
    Z-0932-2013
    Event Number
    62993
    FEI Number
    3010266937
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 24, 2012
    Posted
    March 10, 2013
    Terminated
    May 17, 2013
    Address
    93 Red River St, Spine Smith Partners LP, Austin, TX, 78701-4216

    Description

    Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.

    Reason

    Implants were incorrectly laser marked as 23mm instead of 28mm.

    Action

    Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.

    Distribution

    Distributed in Texas.

    Quantity

    3 units