Invisalign Orthodontic Aligners Recalled for Software Defect Causing Incorrect Quantities
Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The software defect poses a risk to orthodontic treatment efficacy through incorrect aligner production and packaging errors, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Align Technology Inc is recalling three Invisalign orthodontic aligner products: Invisalign Express 10 (REF 8512), Invisalign System Comprehensive (REF 9000), and Invisalign System Moderate (REF 9001). The recall affects 14 cases containing 637 aligners and temples.
The recall was initiated due to a defect in the 3D orthodontic planning software. This defect can cause an incorrect number of aligners to be produced—either fewer or more than the doctor requested—and result in incorrect packaging being provided.
The affected products were distributed in Arizona, California, Colorado, Florida, Kentucky, Massachusetts, New Jersey, New York, Ohio, Oklahoma, and Wisconsin.
Consumers who have received any of these recalled Invisalign products should contact Align Technology Inc for further instructions. Do not use the product if you suspect you have received an incorrect number of aligners or incorrect packaging.
The recalled product
- Product
- Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
- Manufacturer
- Align Technology Inc
Distribution
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