BEUDAMED
    FDA Enforcement Class II Terminated

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    Recall: Z-0160-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0160-2022
    Event ID
    88812
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 27, 2021
    Initiation Date
    October 1, 2021
    Classification Date
    October 21, 2021
    Termination Date
    June 27, 2024
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    Reason

    There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

    Code Info

    2103825

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.

    Quantity

    200 units