FDA Device recall Z-1565-2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
- FDA Device
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of Nobel Biocare N1 TiUltra TCC NP 3.5x13mm by Nobel Biocare, citing due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1565-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-25 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nobel Biocare |
| Distribution | US |
Product
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Reason
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Identifiers
| code_info | Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 121678…Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227 |
|---|
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-1565-2022%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.