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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

3M Clarity Precision Grip Attachments Recalled for Fitting Issues

Agency Publication Date: December 23, 2024
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Summary

3M Company - Health Care Business is recalling Clarity Precision Grip Attachments used in orthodontic treatments. The attachments may not fit the patient's teeth as intended by the digital treatment design. This recall affects 171 orders of the Dual Arch Attachments, and no injuries or incidents have been reported at this time.

Risk

The attachments may fail to mate correctly with the tooth, which can lead to inaccuracies in orthodontic movement and the failure of the digital treatment plan to align with physical results.

What You Should Do

  1. This recall affects 3M Clarity Precision Grip Dual Arch Attachments used for orthodontic treatment.
  2. Check your clinical inventory for products with part numbers 359-830, 359-831, 359-832, 359-833, 359-834, 359-835, 359-836, or 359-837. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact 3M Company - Health Care Business or your distributor to arrange for a return, replacement, or correction of the devices.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Clarity Precision Grip Attachmentsby 3M
Variants: Dual Arch Attachments
Model / REF:
359-830
359-831
359-832
359-833
359-834
359-835
359-836
359-837
UDI:
00652221307286
00652221307293
00652221307309
00652221307316
00652221307361
00652221307378
00652221307385
00652221307392

Potentially affected units were distributed between 11/22/2024 and 12/20/2024.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95828
Status: Active
Manufacturer: 3M Company - Health Care Business
Sold By: orthodontic clinics; dental professionals
Manufactured In: United States
Units Affected: 171 orders
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.