BEUDAMED
    FDA Recall 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 · Initiated December 17, 2014

    Recall

    Recall Number
    Z-1091-2015
    Event Number
    70166
    Firm
    Stryker Craniomaxillofacial Division
    FEI Number
    3005101424
    Product Code
    FWP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 17, 2014
    Posted
    February 11, 2015
    Terminated
    November 6, 2015
    Address
    750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482

    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.

    Action

    Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at [email protected].

    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