BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

    Recall: Z-2198-2021 · Reported August 11, 2021

    Enforcement

    Recall Number
    Z-2198-2021
    Event ID
    88282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 11, 2021
    Initiation Date
    May 27, 2021
    Classification Date
    August 3, 2021
    Termination Date
    March 21, 2023
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

    Reason

    Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

    Code Info

    Packaged lot number: EHG85 Lot Number engraved on part: CXV34

    Distribution

    US Nationwide Distribution

    Quantity

    130 pieces