BEUDAMED
    FDA Enforcement Class II Terminated

    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

    Recall: Z-1758-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1758-2018
    Event ID
    79850
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    April 2, 2018
    Classification Date
    May 9, 2018
    Termination Date
    October 16, 2019
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

    Reason

    There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

    Code Info

    Lot numbers: T104992, T114599, T140390, T140674, T140675, T140676, T140677, T141539, T143644, T144855, T145296, T145589, T145819, T146660, T147930, T148624, T149725, T149726, T151370, T152806, T152807, T153692, T155648, T156708, T160394, T939640, T987813

    Distribution

    US Nationwide and Canada

    Quantity

    235