BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0245-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0245-2022
    Event ID
    88785
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medicalplastic S.R.L.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 24, 2021
    Initiation Date
    June 17, 2021
    Classification Date
    November 17, 2021
    Address
    Via Saverio Mercadante 15, N/A, Milan, N/A, N/A, 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.

    Code Info

    Lot # 20LP02813, Serial #D147 to D149; Lot # 20LP02812, Serial # D115 to D119 ; Lot # 20LP02816, Serial # D099 to D114 ; Lot # 20HP01926, Serial # D059 to D065 ; Lot # 20LP02819, Serial # D175 to D198 ; Lot # 20LP02818, Serial # D129 to D146 ; Lot # 20LP02815, Serial # D120 to D128 ; Lot # 20MP03078, Serial # D374 ; Lot # 20HP01927, Serial # D278 to D282 ; Lot # 20MP03037, Serial # D294 to D296 ; Lot # 20LP02827, Serial # D199 to D258 ; Lot # 20 MP03036, Serial # D288 to D293 ; Lot # 20MP03077, Serial # D370 to D373 ; Lot # 20MP03035, Serial # D259 to D277 ; Lot # 20MP03041, Serial # D283 to D287 ; Lot # 20MP03049, Serial # D343 to D369 ; Lot # 20MP03048, Serial # D297 to D342 ; Lot # 20MP03123, Serial # D375 to D459 ; Lot # 20HP01928, Serial # D460 to D474 ; Lot # 20MP03126, Serial # D482 to D491 ; Lot # 20MP03125, Serial # D492 to D522 ; Lot # 20MP03124, Serial # D475 to D481 ; Lot # 21BP00265, Serial # D523 to D574 ; Lot # 21BP00266, Serial # D626 to D672 ; Lot # 21BP00271, Serial # D588 to D625 ; Lot # 21BP00272, Serial # D575 to D587 ;

    Distribution

    Memphis, TN

    Quantity

    581 units