BEUDAMED
    FDA Enforcement Class II Terminated

    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

    Recall: Z-1545-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1545-2015
    Event ID
    70906
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Incisive Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 6, 2015
    Initiation Date
    March 19, 2015
    Classification Date
    April 29, 2015
    Termination Date
    July 8, 2015
    Address
    14405 21st Ave N, Plymouth, MN, 55447-4685, United States

    Description

    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

    Reason

    A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.

    Code Info

    Lot 121901

    Distribution

    International Distribution Only - Turkey.

    Quantity

    210 cartons (containing 6 INSORB staplers per carton)