Nobel Biocare Recall 90679
Description: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Nobel Biocare Recall 90679 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1565-2022 |
| Event ID | 90679 |
| Event Description | Nobel Biocare N1 TiUltra TCC NP 3.5x13mm |
| Product Type | Devices |
| Distribution | U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden |
| Quantity | 347 devices |
| Recall Reason | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
| Device Classification | 20220831 |
| Device Code Info | 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 |
| Center Classification Date | 20220823 |
| Recall Initiation Date | 20220725 |
| Recalling Firm | Nobel Biocare |
| Initial Notification | Letter |
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