BEUDAMED
    FDA Enforcement Class II Ongoing

    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

    Recall: Z-1235-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1235-2024
    Event ID
    93924
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 13, 2024
    Initiation Date
    January 24, 2024
    Classification Date
    March 1, 2024
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

    Reason

    Products not sterilized, sterility cannot be confirmed

    Code Info

    UDI: 10886982186034 Lot Number: 19P4364

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

    Quantity

    17 units