BEUDAMED
    FDA Enforcement Class II Completed

    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System

    Recall: Z-0068-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0068-2018
    Event ID
    78109
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2017
    Initiation Date
    September 8, 2017
    Classification Date
    November 6, 2017
    Address
    Via Nazionale 52, Frazione Villanova, San Daniele del Friuli, N/A, N/A, Italy

    Description

    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System

    Reason

    An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.

    Code Info

    Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany

    Quantity

    20 units in (US)