FDA Device recall Z-2336-2021
KeyPrint Soft- bottle, 32.5 oz (1kg)
- FDA Device
- Class II
- ongoing
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of KeyPrint Soft- bottle, 32.5 oz (1kg) by Straumann Usa, citing product label intended for the European community was distributed to the USA market via their US distribution organization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2336-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-25 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Straumann Usa |
| Distribution | US |
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
Reason
Product label intended for the European community was distributed to the USA market via their US distribution organization
Identifiers
| code_info | Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2336-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.