BEUDAMED
    FDA Recall Terminated

    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E

    Recall: Z-2648-2017 · Initiated May 23, 2017

    Recall

    Recall Number
    Z-2648-2017
    Event Number
    77309
    Firm
    Onkos Surgical, Inc.
    FEI Number
    3013450937
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 23, 2017
    Terminated
    June 27, 2018
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714

    Description

    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E

    Reason

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

    Action

    On May 23, 2017 Onkos Surgical distributed Medical Device Recall notices to their customers via courier service. Customers were advised to return the affected parts within 2 business days to: Millstone Medical 8836 Polk Lane, Suite 100 Olive Branch, MS 38654 ATTN: Anwar Powell/Recalled Product (662) 892-3612 ext. 1809. Questions regarding this recall can be addressed to: Jan Triani Senior Director of Quality Assurance and Regulatory Affairs [email protected] (973) 264-5400, M-F 8:30 am - 5:00 pm.

    Distribution

    AZ, IL & KS

    Quantity

    4 units