BEUDAMED
    FDA Recall Open, Classified

    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

    Recall: Z-0245-2022 · Initiated June 17, 2021

    Recall

    Recall Number
    Z-0245-2022
    Event Number
    88785
    Firm
    Medicalplastic S.R.L. Via Saverio Mercadante
    FEI Number
    3002807648
    Product Code
    KTT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 17, 2021
    Address
    15 Milan Italy

    Description

    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

    Reason

    Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.

    Action

    The firm notified its sole consignee of the issue and its intent to recall by email on 06/17/2021. The recalled washers will be replaced.

    Distribution

    Memphis, TN

    Quantity

    581 units