Reported Sep 1, 2021 · Ongoing
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as…
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- 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
- Lot codes and dates
- Lot NumberKJ2858
- Shelf Life (Expiration Date)22 April 2023
- Unique Device Identifier (UDI)+H66842200051/$$3230422KJ2858U
- Amount recalled
- N/A
Where it was sold
- Nationwide
- TX
Why it was recalled
Product label intended for the European community was distributed to the USA market via their US distribution organization
This product could cause temporary or reversible health problems — stop using it.
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