BEUDAMED
    FDA Enforcement Class II Terminated

    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

    Recall: Z-2309-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2309-2020
    Event ID
    85701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    May 14, 2020
    Classification Date
    June 9, 2020
    Termination Date
    April 8, 2021
    Address
    6303 Blue Lagoon Dr Ste 100, N/A, Miami, FL, 33126-6023, United States

    Description

    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

    Reason

    Distributed to the field without having completed design history files or design transfer activities

    Code Info

    Lot Number: 054380 (01)00887868134845(17)251111(10)054380

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.

    Quantity

    15 OUS