BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2733-2016 · Initiated August 24, 2016

    Recall

    Recall Number
    Z-2733-2016
    Event Number
    75028
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    FEI Number
    1000138491
    Product Code
    HBG
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 24, 2016
    Posted
    September 2, 2016
    Terminated
    March 30, 2017
    Address
    3498 W 2400 S, Ste 1050, Salt Lake City, UT, 84119-1135

    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.

    Action

    Consignees notified on August 12, 2016 via letter to identify and return product.

    Distribution

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

    Quantity

    710