BEUDAMED
    FDA Recall Open, Classified

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    Recall: Z-1226-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1226-2023
    Event Number
    91614
    Firm
    Preat Corp
    FEI Number
    2918719
    Product Code
    EMA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 1, 2023
    Posted
    March 6, 2023
    Address
    2625 Skyway Dr, Ste B, Santa Maria, CA, 93455-1405

    Description

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    Reason

    Product is labeled with an incorrect expiration date.

    Action

    The recalling firm issued letters dated 1/30/2023 on 2/1/2023 via certified mail. The reason for recall was explained and the customer/user was instructed to discard or return the product to the recalling firm. A Medical Device Recall Return Response form was enclosed for the customer to acknowledge they have read and understand the recall instructions. If the product was implanted, they are to provide specific implant dates, the quantities implanted, and available tracking information. They are to indicate they have identified and notified their customers who were shipped the product and if they want the recalling firm to conduct the subrecall, they were to attach a list of customers.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. There was also government distribution. The country of Canada.

    Quantity

    652 units