3M Company - Health Care Business: 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

Hazard

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

Details from the source

Reason for recall: Attachments may not mate with the tooth as intended in the digital treatment design. Distribution: Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand. Quantity: 171 orders Lot/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

UPC codes

00652221307286, 00652221307293, 00652221307309, 00652221307316, 00652221307361, 00652221307378, 00652221307385, 00652221307392

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.