BEUDAMED
    FDA Enforcement Class II Terminated

    RSP Impaction Fixture

    Recall: Z-1413-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1413-2017
    Event ID
    76456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    February 9, 2017
    Classification Date
    March 8, 2017
    Termination Date
    October 20, 2017
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    RSP Impaction Fixture

    Reason

    During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

    Code Info

    109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02

    Distribution

    US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

    Quantity

    626 units