BEUDAMED
    FDA Recall Terminated

    Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

    Recall: Z-0691-2020 · Initiated November 4, 2019

    Recall

    Recall Number
    Z-0691-2020
    Event Number
    84320
    Firm
    Integra Lifesciences Sales Llc
    FEI Number
    3001700044
    Product Code
    KYJ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 4, 2019
    Terminated
    May 5, 2020
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

    Reason

    Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant

    Action

    Integra notified by letter consignee via courier service, facsimile or email between November 4th and 6th, 2019, advising reason for recall, health risk and action to take: confirm that the device was actually implanted as part of the above-referenced surgery and, if so, please confirm the date of that surgery. 2. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    9 units