BEUDAMED
    FDA Enforcement Class II Terminated

    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

    Recall: Z-1711-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1711-2016
    Event ID
    73870
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 8, 2016
    Classification Date
    May 24, 2016
    Termination Date
    December 5, 2016
    Address
    Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

    Reason

    Complaints of intra-operative breakage of the glenosphere impactors/extractors.

    Code Info

    Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600

    Distribution

    Distributed US (nationwide) and in Australia.

    Quantity

    314 units