BEUDAMED
    FDA Enforcement Class II Terminated

    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

    Recall: Z-2646-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2646-2017
    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 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E

    Reason

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

    Code Info

    LOT 1700558

    Distribution

    AZ, IL & KS

    Quantity

    4 units