Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Summary
The FDA issued a Class II for Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 by Align Technology Inc. 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 doct.
Details
Source
Device Recall
External ID
Z-1017-2023
Action Date
2023-02-01
Status
Completed
Category
device
Product Description
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Lot/Code Info: Invisalign Express 10 Product Code: 8512 SO/PID: 215086492 / 18752002 Invisalign System - Comprehensive Product Code: 9000 SO / PID: 215072477 / 18747673 213766469 / 17291917 215237342 / 16525818 215211007 / 18799320 215234241 / 15985771 215275953 / 18824845 215035759 / 16193974 215038858 / 18715205 215349325 / 18799786 215125907 / 18746963 215541695 / 16576036 215451877 / 14994856 Invisalign System - Moderate Product Code: 9001 SO/PID: 214866511 / 18672529
Quantity Affected: 14 cases (637 aligner and temples)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-05
Company
San Jose, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Align Technology Inc has 8 FDA actions in our database, including 1 recall and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Align Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Align Technology Inc have FDA actions?
Align Technology Inc has 8 FDA actions in our database, including 1 recall and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1017-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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