Straumann USA LLC Recall 88427
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
Straumann USA LLC Recall 88427 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2336-2021 |
| Event ID | 88427 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution in the state of TX. |
| Recall Reason | Product label intended for the European community was distributed to the USA market via their US distribution organization |
| Device Classification | 20210901 |
| Device Code Info | Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U |
| Center Classification Date | 20210824 |
| Recall Initiation Date | 20210625 |
| Recalling Firm | Straumann USA LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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