Device product

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Z-1565-2022

July 25, 2022

Class II

Product summary

Firm: Nobel Biocare
Event: Event 90679
Status: Ongoing
Classification: Class II
Quantity: 347 devices
Official record key: device-enforcement:Z-1565-2022

Official wording

Reason: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

Code information: 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

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.