BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

    Recall: Z-2235-2024 · Initiated May 17, 2024

    Recall

    Recall Number
    Z-2235-2024
    Event Number
    94745
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    FEI Number
    3012120772
    Product Code
    GAD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 17, 2024
    Posted
    June 28, 2024
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608

    Description

    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 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

    Action

    On May 17, 2024, SeaSpine Orthopedics Corporation issued a "Urgent: Medical Device Recall" notification. via E-Mail (DocuSign) to affected consignees. 1. Please return the entire Fathom set to SeaSpine s Carlsbad facility for evaluation and potential rework of the affected blades. A shipping label is attached for your convenience. 2. To support your upcoming cases, please continue to utilize the loaner pool. Upon receipt of the affected inventory, it will take approximately three weeks for rework and return to the loaner pool. 3. Once the inventory has been returned, please acknowledge via DocuSign.

    Distribution

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

    Quantity

    31 units