BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

    Recall: Z-2234-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2234-2024
    Event ID
    94745
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 10, 2024
    Initiation Date
    May 17, 2024
    Classification Date
    June 28, 2024
    Address
    5770 Armada Dr, N/A, Carlsbad, CA, 92008-4608, United States

    Description

    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

    Reason

    Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

    Code Info

    UDI: 10889981300050 Lot Number: WT36298C

    Distribution

    United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.

    Quantity

    21 units