BEUDAMED
    FDA Enforcement Class II Ongoing

    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

    Recall: Z-3021-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3021-2020
    Event ID
    86317
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 7, 2020
    Initiation Date
    August 7, 2020
    Classification Date
    September 25, 2020
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

    Reason

    Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

    Code Info

    Part 509-00-044, Lot 380P1009A , UDI: 00888912144568

    Distribution

    Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA

    Quantity

    15 units