BEUDAMED
    FDA Recall Open, Classified

    Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

    Recall: Z-1171-2023 · Initiated January 13, 2023

    Recall

    Recall Number
    Z-1171-2023
    Event Number
    91527
    Firm
    Summit Medical, LLC
    FEI Number
    3008719017
    Product Code
    LFB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 13, 2023
    Posted
    February 24, 2023
    Address
    815 Vikings Pkwy, Ste 100, Eagan, MN, 55121-1139

    Description

    Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

    Reason

    Sterile product pouches were not sealed.

    Action

    The firm issued "URGENT RECALL NOTICE" Letters dated 1/13/2023 via email. The letter explained the issue and requested the consignee remove the product from inventory and inspect the pouch to verify it is sealed. If the pouch is not sealed, the consignee is to cut the product with scissors and dispose of it. Results of their inspection are to be reported to the recalling firm by email using the enclosed form. A number is listed to arrange for replacement product. The consignee is to indicate on the form that they have read and understand the recall instructions, have checked their stock and disposed of inventory affected, and that they have none of the product left in inventory. If you have any questions, contact Director of Quality Assurance at 651-789-3939 or email: [email protected].

    Distribution

    US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.

    Quantity

    30 devices