Z-2336-2021Class II

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as...

Name: Z-2336-2021 KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as...
Creator: Straumann USA LLC
Published: 2021-06-25
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2021-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Straumann USA LLC began a recall of KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and... on 2021-06-25. FDA classified it as Class II and gives the reason as "Product label intended for the European community was distributed to the USA market via their US distribution organization". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2336-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-25
Posted: 2021-08-24
Recalling firm: Straumann USA, LLC
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
Product code: MQC Mouthguard, Prescription
Reason for recall: Product label intended for the European community was distributed to the USA market via their US distribution organization
Root cause tag: manufacturing process
FDA 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.
Product codes and lots: Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2336-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-24

Product code MQC

K183598UnclassifiedKeyPrint KeySplint SoftKeystone Industries / cleared 2019-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)