Nobel Biocare 2022-08-31 Health serious FDA
Health · FDA · Recall #FDA-Z-1565-2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Recall
Issued August 31, 2022 · Nobel Biocare
In August 2022, Nobel Biocare recalled the Nobel Biocare N1 TiUltra TCC NP 3.5x13mm, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
What you should do
- 1 Stop using Nobel Biocare N1 TiUltra TCC NP 3.5x13mm right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Nobel Biocare to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Nobel Biocare
- Category
- Health
- Recall date
- August 31, 2022
- Units affected
- Not reported
- Sold at
- 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 Kingdo
- Recall number
- FDA-Z-1565-2022
- Made in
- Sweden
- Issuing agency
- FDA
In context
- Nobel Biocare has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.