3M Clarity recallZ-0743-2025 · 3M Company - Health Care Business · initiated Nov 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Attachments may not mate with the tooth as intended in the digital treatment design.
FDA root cause category: Software design (manufacturing process)
What the company is doing
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].
Recall details
- Recall number
- Z-0743-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 22, 2024
- Posted by the FDA
- Dec 23, 2024
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 171 orders
- Product code
- NXC
- FDA submissions
- K233257
- Distribution
- Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- 3M™ Clarity™ 359-8303m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8313m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8323m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8333m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8343m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8353m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
- 3M™ Clarity™ 359-8373m Unitek Corporation · Aligner, sequential1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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