BEUDAMED
    FDA Enforcement Class II Terminated

    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E

    Recall: Z-2647-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2647-2017
    Event ID
    77309
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Onkos Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    May 23, 2017
    Classification Date
    June 29, 2017
    Termination Date
    June 27, 2018
    Address
    77 E Halsey Rd, N/A, Parsippany, NJ, 07054-3714, United States

    Description

    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E

    Reason

    The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

    Code Info

    LOT 1700559

    Distribution

    AZ, IL & KS

    Quantity

    4 units