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Recall Observatory FDA recall evidence

Device 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

Z-0743-2025

November 22, 2024

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 95828
Status
Ongoing
Classification
Class II
Quantity
171 orders
Official record key
device-enforcement:Z-0743-2025

Official wording

Reason: Attachments may not mate with the tooth as intended in the digital treatment design.

Code information: 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

Distribution pattern: Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Attachments may not mate with the tooth as intended in the digital treatment design.