FDA Medical devices recall ·
Clarity Precision Grip Attachments, for use in orthodontic treatment recall
- Recall number
- Z-0743-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- 3M Company
3m Center 2510 Conway Ave, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 171 orders
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Attachments may not mate with the tooth as intended in the digital treatment design.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0743-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.