Recall Z-1565-2022— Nobel Biocare

Name: FDA recall Z-1565-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-25

Class II · Ongoing

Class II FDA medical device recall by Nobel Biocare, initiated 2022-07-25. It names one FDA 510(k) clearance: K211109. Product: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm. Reason: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure..

Recalling firm: Nobel Biocare
Classification: Class II
Status: Ongoing
Initiated: 2022-07-25
Firm location: Goteborg, Sweden

510(k) clearances named in this recall

1 on FDA's record

K211109 — N1 TiUltra TCC Implant SystemNobel Biocare Services AG·cleared 2021-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.