Clarity Precision Grip Attachments (3M) – Tooth Mating Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
3M Company Health Care Business 3m Center
Lot Codes / Batch Numbers
359-831/ 00652221307293, 359-832/00652221307309, 359-833/ 00652221307316, 359-834/ 00652221307361, 359-835/ 00652221307378, 359-836/ 00652221307385, 359-837/ 00652221307392
Products Sold
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
3M Company Health Care Business 3m Center is recalling Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 3 due to Attachments may not mate with the tooth as intended in the digital treatment design.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Attachments may not mate with the tooth as intended in the digital treatment design.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026