Z-0743-2025 Class II Ongoing
FDA device recall Z-0743-2025 was initiated by 3M Company - Health Care Business on November 22, 2024 and is designated Class II. Reason for recall: Attachments may not mate with the tooth as intended in the digital treatment design. The recall status is ongoing. Affected quantity: 171 orders.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171 orders
Product 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 for Recall
Attachments may not mate with the tooth as intended in the digital treatment design.
Distribution Pattern
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
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