Jan

2023

Recall: Software Defect Leads to Incorrect Number of Aligners Produced

Allison Pate

News

fda, recall

Company: Align Technology Inc.
Date of Enforcement Report: 1/26/2023
Class II

PRODUCT

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

Recall Number:

Z-1017-2023

REASON

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.

RECALLING FIRM/MANUFACTURER

Align Technology Inc

VOLUME OF PRODUCT IN COMMERCE

14 cases (637 aligner and temples)

DISTRIBUTION

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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Recall: Software Defect Leads to Incorrect Number of Aligners Produced

Allison Pate

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