KeyPrint Soft- bottle — Class II medical device recall Z-2336-2021
Ongoing recall by Straumann USA LLC, reported 2021-09-01, distributed nationwide. Product label intended for the European community was distributed to the USA market via their US distribution
| Recall number | Z-2336-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2021-06-25 |
| Classified | 2021-08-24 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | KJ2858 |
| Model numbers | 4220005 |
| Expiration dates | 2023-04-22 |
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 for recall
Product label intended for the European community was distributed to the USA market via their US distribution organization
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2336-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.