Recall Z-2336-2021 ยท MQC Mouthguard, Prescription
Straumann USA LLC
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
| Date | Jun 25, 2021 |
| Status | Open, Classified |
| Reason | Product label intended for the European community was distributed to the USA market via their US distribution organization |
| Root cause | Process control |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183598 | KeyPrint KeySplint Soft Keystone Industries, Nov 15, 2019 |