BEUDAMED
    FDA Enforcement Class II Terminated

    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

    Recall: Z-2236-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2236-2021
    Event ID
    88307
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NEOSTEO
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    November 3, 2020
    Classification Date
    August 9, 2021
    Termination Date
    December 6, 2021
    Address
    2 rue Robert Schuman, N/A, Reze, N/A, N/A, France

    Description

    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

    Reason

    Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.

    Code Info

    Lot: 243-20

    Distribution

    US Nationwide distribution in the state of New Jersey.

    Quantity

    25