Reported Aug 31, 2022 · Ongoing

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Nobel Biocare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nobel Biocare · Vastra Hamngatan 1 · Goteborg · N/A

Is this the product you have?

  • Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Lot codes and dates
  • Catalog number300859
  • Lot numbers / UDI Codes12167337 / (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
Amount recalled
347 devices

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Nobel Biocare recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.