BEUDAMED
    FDA Enforcement Class II Terminated

    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

    Recall: Z-0639-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0639-2017
    Event ID
    75502
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    October 3, 2016
    Classification Date
    November 19, 2016
    Termination Date
    July 6, 2017
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

    Reason

    The peel pouches for the affected reaming rods and extraction hooks are delaminating.

    Code Info

    Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.

    Distribution

    Distributed Nationwide

    Quantity

    5478 units