BEUDAMED
    FDA Enforcement Class II Terminated

    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.

    Recall: Z-2600-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2600-2016
    Event ID
    74855
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 21, 2016
    Classification Date
    August 19, 2016
    Termination Date
    March 29, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.

    Reason

    Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".

    Code Info

    Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S

    Distribution

    US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA

    Quantity

    120 units from multiple lots