—#188615

Product

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 product code: MQC — Mouthguard, Prescription
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K183598
Affected lot / code info: Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Straumann USA LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Nationwide distribution in the state of TX.

Timeline

Recall initiated: 2021-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.