BEUDAMED
    FDA Enforcement Class II Terminated

    EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

    Recall: Z-2945-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2945-2020
    Event ID
    86342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 16, 2020
    Initiation Date
    August 24, 2020
    Classification Date
    September 9, 2020
    Termination Date
    July 11, 2022
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

    Reason

    Multiple or incorrect expiration dates were provided on the affected designation labels.

    Code Info

    Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.

    Distribution

    International Distribution to the countries of Denmark, Sweden, France and Spain.

    Quantity

    71 units