# FDA recall Z-1565-2022

> **Nobel Biocare** · Class II · device recall initiated 2022-07-25.

## 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

- **Recall number:** Z-1565-2022
- **Recalling firm:** Nobel Biocare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-25
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goteborg, Sweden

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1565-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1565-2022. Source: US FDA. Licensed CC0.

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