BEUDAMED
    FDA Enforcement Class II Terminated

    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    Recall: Z-0989-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0989-2015
    Event ID
    69997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med Tec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 21, 2015
    Initiation Date
    December 11, 2014
    Classification Date
    January 15, 2015
    Termination Date
    February 3, 2017
    Address
    1401 8th St SE, PO Box 320, Orange City, IA, 51041-7463, United States

    Description

    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    Reason

    The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

    Code Info

    Lot: M612690 REF: 20SR02SUB2

    Distribution

    Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.

    Quantity

    11