# FDA recall Z-1017-2023

> **Align Technology Inc** · Class II · device recall initiated 2022-12-05.

## Product

Invisalign Express 10 REF 8512    Invisalign System   Comprehensive REF 9000    Invisalign System   Moderate REF 9001

## Reason for recall

3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.

## Distribution

U.S. Nationwide distribution in the states of  AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.

## Key facts

- **Recall number:** Z-1017-2023
- **Recalling firm:** Align Technology Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-12-05
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2023

## Citation

> AI Analytics. FDA recall Z-1017-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1017-2023. Source: US FDA. Licensed CC0.

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