BEUDAMED
    FDA Enforcement Class II Terminated

    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

    Recall: Z-2733-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2733-2016
    Event ID
    75028
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    August 24, 2016
    Classification Date
    September 2, 2016
    Termination Date
    March 30, 2017
    Address
    3498 W 2400 S Ste 1050, Salt Lake City, UT, 84119-1135, United States

    Description

    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

    Reason

    Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

    Code Info

    Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12

    Distribution

    Nationwide and VA/govt/military. No foreign consignees.

    Quantity

    710