BEUDAMED
    FDA Enforcement Class II Ongoing

    EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S

    Recall: Z-1324-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1324-2022
    Event ID
    90390
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    May 20, 2022
    Classification Date
    July 1, 2022
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S

    Reason

    Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

    Code Info

    UDI-DI: 04260557770573 Lot Number: E20CL0637

    Distribution

    Distribution US Nationwide

    Quantity

    46 units