BEUDAMED
    FDA Enforcement Class II Ongoing

    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

    Recall: Z-1419-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1419-2022
    Event ID
    90557
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 27, 2022
    Initiation Date
    June 29, 2022
    Classification Date
    July 20, 2022
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

    Reason

    Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

    Code Info

    GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

    Distribution

    Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

    Quantity

    872 units