BEUDAMED
    FDA Recall 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 · Initiated July 21, 2016

    Recall

    Recall Number
    Z-2600-2016
    Event Number
    74855
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 21, 2016
    Terminated
    March 29, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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".

    Action

    Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to [email protected] or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873.

    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