BEUDAMED
    FDA Recall 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 · Initiated August 18, 2021

    Recall

    Recall Number
    Z-2506-2021
    Event Number
    88510
    Firm
    In2bones USA, LLC
    FEI Number
    3011580264
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 18, 2021
    Terminated
    August 8, 2023
    Address
    6000 Poplar Ave, Ste 115, Memphis, TN, 38119-3981

    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.

    Action

    The recall letter dated 8/17/2021 was issued by the recalling firm via FedEx on 8/18/2021. It explains the description of the issue, associated risks, and requests the letter recipient to distribute the recall notice to all relevant persons within their organization. The consignee is to identify and quarantine the affected product for return to the firm.

    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