BEUDAMED
    FDA Enforcement Class II Ongoing

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    Recall: Z-1430-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1430-2023
    Event ID
    91968
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    February 23, 2023
    Classification Date
    April 25, 2023
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    Reason

    Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

    Code Info

    GUIDID: 04046955299592 (Basket Lid)

    Distribution

    US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.

    Quantity

    ME754: 3 units; ME764: 22 units