Nobel Biocare N1 TiUltra TCC NP 3 — Class II medical device recall Z-1565-2022
Ongoing recall by Nobel Biocare, reported 2022-08-31, distributed nationwide. Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
| Recall number | Z-1565-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare, Goteborg, Sweden |
| Recall initiated | 2022-07-25 |
| Classified | 2022-08-23 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, ES, FR, GB, HU, IS, IT, NL, NO, PT, SE |
| Quantity | 347 devices |
| UPC / GTIN / UDI-DI | 07332747161717 |
| Model numbers | 300859 |
Product
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Reason for recall
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
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-1565-2022. 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.