Drug recall
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as…
FDA recall event 88427 · Class II · Straumann USA LLC
Key facts
| Event ID | 88427 |
|---|---|
| Recall numbers | Z-2336-2021 |
| Recalling firm | Straumann USA LLC |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product label intended for the European community was distributed to the USA market via their US distribution organization |
| Initiation date | Jun 25, 2021 |
| Report date | Sep 1, 2021 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1000121052 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: