BEUDAMED
    FDA Enforcement Class II Terminated

    CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.

    Recall: Z-2506-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2506-2021
    Event ID
    88510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2bones USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 18, 2021
    Classification Date
    September 22, 2021
    Termination Date
    August 8, 2023
    Address
    6000 Poplar Ave Ste 115, Memphis, TN, 38119-3981, United States

    Description

    CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.

    Reason

    Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

    Code Info

    Lot Numbers: 992921, 1018971, 1046581, and 1070081.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, LA, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, VA, and WI. There was no military/government distribution.

    Quantity

    835 units