- 76 records; 74 terminated.1
- Most concern specific lots, labels, instruments or packaging.
- Your lot number decides whether a notice concerns you.
The two open records
Both concern Nobel Biocare N1™ TiUltra TCC products: a possible burr on a co-packed OsseoShaper™ instrument (2022) and a packaging pin that could breach sterility (2025).1
Last updated 28 Sep 2026 · How we review
Sources
- Regulatory recordopenFDA device recall database — records with recalling firm "Nobel Biocare" (76 records) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.
Educational information only. The choice of implant system depends on your anatomy, restorative plan, bone quality and the clinician's assessment. This website does not recommend a specific implant for you.