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Recall

Class II — 3M Company - Health Care Business

Recalling firm3M COMPANY
Registered facilityView this company's 13 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonAttachments may not mate with the tooth as intended in the digital treatment design.
ProductClarity 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
Quantity171 orders
DistributionProduct was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Initiated2024-11-22
Classified2024-12-20
Recall numberZ-0743-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — 3M Company - Health Care Business (Z-0743-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95828/

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