BEUDAMED
    FDA Recall Open, Classified

    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

    Recall: Z-2336-2021 · Initiated June 25, 2021

    Recall

    Recall Number
    Z-2336-2021
    Event Number
    88427
    Firm
    Straumann USA LLC
    FEI Number
    1000121052
    Product Code
    MQC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 25, 2021
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

    Reason

    Product label intended for the European community was distributed to the USA market via their US distribution organization

    Action

    Straumann USA initial notification to the customer via phone call on 25 June 2021. A follow-up letter dated 7/2/21 issued. Letter states reason for recall, health risk and action to take: Action to be taken: 1. Based on our conversation on 25 June 2021, you did not use and you have segregated the product and it was made ready to ship back to us. 2. Complete and return the enclosed Customer Confirmation Form to FSCA ER21-0118, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 along with the product using the attached label.

    Distribution

    US Nationwide distribution in the state of TX.