FDA Enforcement
Class II
Ongoing
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
Recall: Z-0743-2025
·
Reported January 1, 2025
Enforcement
- Recall Number
- Z-0743-2025
- Event ID
- 95828
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- 3M Company - Health Care Business
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 1, 2025
- Initiation Date
- November 22, 2024
- Classification Date
- December 20, 2024
- Address
- 3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States
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
Reason
Attachments may not mate with the tooth as intended in the digital treatment design.
Code Info
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.
Quantity
171 orders