Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832
Summary
The FDA issued a Class II for Clarity Precision Grip Attachments, for use in orthodontic treatment. Part nu by 3M Company - Health Care Business. Reason: Attachments may not mate with the tooth as intended in the digital treatment design..
Details
Source
Device Recall
External ID
Z-0743-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
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
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
Quantity Affected: 171 orders
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Company - Health Care Business) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Company - Health Care Business have FDA actions?
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0743-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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