BEUDAMED
    FDA Enforcement Class II Terminated

    MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

    Recall: Z-1091-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1091-2015
    Event ID
    70166
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Craniomaxillofacial Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    December 17, 2014
    Classification Date
    February 11, 2015
    Termination Date
    November 6, 2015
    Address
    750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482, United States

    Description

    MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

    Reason

    Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

    Code Info

    Part Number 9305; Lot Numbers 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010

    Distribution

    Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.

    Quantity

    1051