Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833
FDA device recall Z-0743-2025 · posted 2024-12-23 · Open, Classified
Recall details
- Recalling firm
- 3M Company - Health Care Business
- Reason for recall
- Attachments may not mate with the tooth as intended in the digital treatment design.
- Action taken
- 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, contact the Clinician Support team (800-423-4588, option 2) or customortho@solventum.com.
- Root cause
- Software design (manufacturing process)
- Status
- Open, Classified
- Product code
- NXC
- Quantity affected
- 171 orders
- Distribution
- Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
- Date initiated
- 2024-11-22
- Date posted
- 2024-12-23
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M™ Clarity™Aligners with Quick Attachments (K233257) | 3M Company, Unitek Orthodontic Products | 2023-09-29 |