BEUDAMED
    FDA Enforcement Class II Terminated

    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws

    Recall: Z-2084-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2084-2016
    Event ID
    74224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    May 20, 2016
    Classification Date
    June 28, 2016
    Termination Date
    November 16, 2016
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws

    Reason

    The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.

    Code Info

    Lot 237830TE

    Distribution

    Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA

    Quantity

    182 units