BEUDAMED
    FDA Enforcement Class II Terminated

    ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915

    Recall: Z-0397-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0397-2020
    Event ID
    84004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix Srl
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    September 27, 2018
    Classification Date
    November 14, 2019
    Termination Date
    February 1, 2022
    Address
    Via Delle Nazioni 9 O 73, N/A, Veronaverona, N/A, N/A, Italy

    Description

    ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915

    Reason

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

    Code Info

    Lot # B1200709, B1204115, B1206439, B1225414, B1233729

    Distribution

    US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel

    Quantity

    N/A