Exact FDA event identifier

Event 88427

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: June 25, 2021
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Straumann USA LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Recall number: Z-2336-2021
Initiated: June 25, 2021
Classification: Class II
Status: Ongoing
Recalling firm: Straumann USA LLC
Quantity: N/A

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.