Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Recalled by Nobel Biocare Due to Due to the presence of a burr which...

Date: July 25, 2022
Company: Nobel Biocare
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare directly.

Affected Products

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Quantity: 347 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nobel Biocare

Nobel Biocare has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report