BEUDAMED
    FDA Enforcement Class II Terminated

    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

    Recall: Z-1133-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1133-2015
    Event ID
    70401
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 4, 2015
    Initiation Date
    December 17, 2014
    Classification Date
    February 20, 2015
    Termination Date
    September 23, 2015
    Address
    Sulzer Allee 8, N/A, Winterthur, N/A, N/A, Switzerland

    Description

    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

    Reason

    Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

    Code Info

    Item numbers: 19.32.05; 19.32.06; 19.32.08; Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398

    Distribution

    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan

    Quantity

    30