FDA recall Z-1565-2022

Product

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-07-25

Report date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Goteborg, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2022