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Nobel Biocare recalls Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Recalled August 31, 2022 · FDA recall Z-1565-2022 · Nobel Biocare
Hazard
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. · FDA Class II
Units
347 devices
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 Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
Description
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Product
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Manufacturer(s)
Nobel Biocare
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →