Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Recall Insight

This FDA Devices action (record #Z-1565-2022) was formally reported on August 31, 2022, with the manufacturer initiating the action on July 25, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Nobel Biocare is listed as the recalling firm, operating out of Goteborg. Federal records indicate 347 devices units are affected.

The documented reason for this recall is: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.