BEUDAMED
    FDA Enforcement Class II Terminated

    BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

    Recall: Z-1299-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1299-2013
    Event ID
    64778
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    March 28, 2013
    Classification Date
    May 10, 2013
    Termination Date
    June 3, 2015
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339, United States

    Description

    BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

    Reason

    Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

    Code Info

    1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

    Quantity

    20,032 boxes