Recall record at a glance
| Official record | Z-1017-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Align Technology Inc. |
| Report date | Feb 1, 2023 |
| Recall initiation date | Dec 5, 2022 |
| Quantity | 14 cases (637 aligner and temples) |
| Location | San Jose, CA, United States |
Official product description
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Why the product was recalled
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 information
U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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