BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0932-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0932-2013
    Event ID
    62993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spine Smith Partners LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    August 24, 2012
    Classification Date
    March 10, 2013
    Termination Date
    May 17, 2013
    Address
    93 Red River St, N/A, Austin, TX, 78701-4216, United States

    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.

    Code Info

    Part Number: 0609-2809-06, Lot: 39AQ

    Distribution

    Distributed in Texas.

    Quantity

    3 units