Z-0743-2025Class II

Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831...

Name: Z-0743-2025 Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831...
Creator: 3M Company - Health Care Business
Published: 2024-11-22
License: https://open.fda.gov/license/

3M Company / initiated 2024-11-22 / Open, Classified / root cause: software

FDA source

3M Company - Health Care Business began a recall of 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 on 2024-11-22. FDA classified it as Class II and gives the reason as "Attachments may not mate with the tooth as intended in the digital treatment design". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0743-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-22
Posted: 2024-12-23
Recalling firm: 3M Company
Product: 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
Product code: NXC Aligner, Sequential
Reason for recall: Attachments may not mate with the tooth as intended in the digital treatment design.
Root cause tag: software
FDA 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, contact the Clinician Support team (800-423-4588, option 2) or [email protected].
Quantity in commerce: 171 orders
Distribution: Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Product codes and lots: Only 3M Clarity Precision Grip Attachment Dual Arch Attachments are potentially affected. Part numbers/UDI-DI: 359-830/ 00652221307286; 359-831/ 00652221307293; 359-832/00652221307309; 359-833/ 00652221307316; 359-834/ 00652221307361; 359-835/ 00652221307378; 359-836/ 00652221307385; 359-837/ 00652221307392

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0743-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0743-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code NXC

K233257Class II3M™ Clarity™Aligners with Quick Attachments3M Company, Unitek Orthodontic Products / cleared 2023-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)