BEUDAMED
    FDA Recall Terminated

    Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

    Recall: Z-1945-2015 · Initiated June 3, 2015

    Recall

    Recall Number
    Z-1945-2015
    Event Number
    71526
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 3, 2015
    Posted
    July 1, 2015
    Terminated
    December 22, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

    Reason

    Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.

    Action

    On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

    Quantity

    41 units