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Recall Observatory FDA recall evidence

Device 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

Z-2336-2021

June 25, 2021

Class II

Product summary

Firm
Straumann USA LLC
Event
Event 88427
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2336-2021

Official wording

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

Code information: Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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