Recall Z-0743-2025 · NXC Aligner, Sequential
3M Company - Health Care Business
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
| Date | Dec 23, 2024 (initiated Nov 22, 2024) |
| Status | Open, Classified |
| Reason | Attachments may not mate with the tooth as intended in the digital treatment design. |
| Root cause | Software design (manufacturing process) |
| Action | On November 22, 2024, the firm notified customers via URGENT Product Recall letters. Customers were informed that select grip attachments were impacted by a software nonconformance, limited to the lower arch of specific dual-arch Clarity Precision Grip Attachment orders. The firm advises that customers not use products from the identified Case IDs, and that they should dispose of affected products. Customers should complete and return the included customer product destruction form. The firm will provide replacement product. If you have additional questions or need to report an adverse event, |
| Quantity | 171 orders |
| Distribution | Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233257 | 3M ClarityAligners with Quick Attachments 3M Company, Unitek Orthodontic Products, Sep 29, 2023 |