Straumann USA LLC: Medical Device Recall in 2021 - (Recall #: Z-2336-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 25, 2021

Date Posted: September 1, 2021

Recall Number: Z-2336-2021

Event ID: 88427

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

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.

Voluntary or Mandated:

Voluntary: Firm initiated