BEUDAMED
    FDA Enforcement Class II Terminated

    Normed Charcot Osteotome Chisel (Various sizes)

    Recall: Z-1360-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1360-2018
    Event ID
    79495
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    March 15, 2018
    Classification Date
    April 11, 2018
    Termination Date
    April 25, 2019
    Address
    Sulzerallee 8, Winterthur, N/A, Switzerland

    Description

    Normed Charcot Osteotome Chisel (Various sizes)

    Reason

    Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.

    Code Info

    Models: 26.08.506 OSTEO 8MM AND W/HDL 20CM/8IN 26.08.507 OSTEO 10MM AND W/HDL 20CM/8IN 26.08.508 OSTEO 12MM AND W/HDL 20CM/8IN 26.08.509 OSTEO 13MM CRVD R 10 23CM/9IN 26.08.619 OSTEO 19MM CRVD R 10 23CM/9IN (No US distribution) 26.08.712 OSTEO 12MM CRVD R 6 23CM/9IN (No US distribution) 26.08.715 OSTEO 15MM CRVD R 6 23CM/9IN (No US distribution) 26.08.718 CHARC OSTE 18MM CRD R6 23CM/9 26.08.812 OSTEO 12MM CRVD R 8 23CM/9IN (No US distribution) 26.08.815 OSTEO 15MM CRVD R 8 23CM/9IN (No US distribution) 26.08.818 CHARC OSTE 18MM CRD R8 23CM/9 (No US distribution) 26.08.900 ARTHROPIC ARTH 18CM 45TUFF HDL 26.08.910 RUTREK CHIS 20CM/8 DBL CUT BLD

    Distribution

    CO, IN, TX, IL