BEUDAMED
    FDA Enforcement Class II Terminated

    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

    Recall: Z-1126-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1126-2020
    Event ID
    84706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 9, 2019
    Classification Date
    February 10, 2020
    Termination Date
    April 27, 2021
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

    Reason

    Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

    Code Info

    Lot # 109038 No affected devices distributed within the US.

    Distribution

    US: None OUS: Iceland, Sweden, Spain,

    Quantity

    11 units