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
FDA Recall Z-0743-2025 · Posted 2024-12-23
Recalling Firm3M Company - Health Care Business
Recall StatusOpen, Classified
Product CodeNXC
Date Initiated2024-11-22
Product Quantity171 orders
Reason for Recall
Attachments may not mate with the tooth as intended in the digital treatment design.
Firm 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, contact the Clinician Support team (800-423-4588, option 2) or
[email protected].
Root Cause
Software design (manufacturing process)
Distribution Pattern
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.