FDA recall Z-0743-2025

3M Company - Health Care Business · Class II · device

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

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.

Key facts

Status: Ongoing
Initiation date: 2024-11-22
Report date: 2025-01-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2025