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
FDA Recall Z-2336-2021 · Posted None
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Recalling FirmStraumann USA LLC
Recall StatusOpen, Classified
Product CodeMQC
Date Initiated2021-06-25
Reason for Recall
Product label intended for the European community was distributed to the USA market via their US distribution organization
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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