The Recall Desk
HighFDA (Devices)·Z-1565-2022·Announced 2022-08-31

Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk

Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a medical device with an identified aspiration hazard during surgical use. No illnesses or injuries have been reported. This is classified as High severity because it is a risk-of-harm product where injury has not yet been reported, consistent with the severity rubric.

Plain-English summary

Nobel Biocare is recalling 347 N1 TiUltra TCC NP 3.5x13mm dental implants due to the presence of a burr on the device. This burr may create an aspiration risk to patients during the surgical implantation procedure.

The affected devices have catalog number 300859 and were distributed in the United States (including Arizona, California, Connecticut, Florida, Hawaii, North Carolina, New York, Oregon, Pennsylvania, Texas, Utah, and Wisconsin) and internationally (Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden).

Patients who have received these implants or healthcare providers who have used or have these devices in stock should contact Nobel Biocare for guidance on appropriate next steps. No illnesses or injuries have been reported to date.

The recalled product

Product
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Manufacturer
Nobel Biocare
Category
Medical Device — Dental Implant
Hazard
Affected units
347

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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