BEUDAMED
    FDA Enforcement Class II Terminated

    Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    Recall: Z-1291-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1291-2013
    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

    Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    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

    1125130 ,1125686 1125687, 1125688 1126015, 1105298 1110145, 1110674 1111854, 1104502 1104503, 1105309 1105310, 1110249 1111366, 1111367 1111368, 1111370 1112262

    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

    49,500 boxes