BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    Recall: Z-2357-2024 · Initiated June 4, 2024

    Recall

    Recall Number
    Z-2357-2024
    Event Number
    94872
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    FEI Number
    3012120772
    Product Code
    HWJ
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    June 4, 2024
    Posted
    July 15, 2024
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608

    Description

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    Reason

    Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

    Action

    On June 4, 2024, SeaSpine Orthopedics issued a "Urgent Medical Device Recall" Notification via E-Mail to affected consignees. SeaSpine Orthopedics ask consignees to take the following actions: We request that you return the affected part to SeaSpine s Carlsbad facility for evaluation and potential rework. To support your upcoming cases, a replacement Vu aPod Prime NM Angled Awl will be sent (PN: 33-40-1028). Additionally, please continue to utilize the loaner pool. Please use the attached label to return the inventory in your possession at your earliest convenience. Once the inventory has been returned, please acknowledge via DocuSign.

    Distribution

    The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona

    Quantity

    100 units