BEUDAMED
    FDA Enforcement Class II Terminated

    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

    Recall: Z-0199-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0199-2015
    Event ID
    69271
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    October 15, 2014
    Classification Date
    November 10, 2014
    Termination Date
    November 19, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

    Reason

    Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.

    Code Info

    Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ABB49200 B49200 ABB50724 B50724 ABB55749 B55749 ABB63598 B63598 ABB66346 B66346 ABB72107 B72107 ABB77183 B77183 ABB79390 B79390 ABB79391 B79391 ABB80712 N80712 ABC17165 C17165 ABC5023 C5023

    Distribution

    Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.

    Quantity

    3,082