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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Clarity Precision Grip Attachments

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 Class 2 Device Recall 3M Clarity Precision Grip Attachmentssee related information
Date Initiated by FirmNovember 22, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0743-2025
Recall Event ID 95828
510(K)NumberK233257 
Product Classification Aligner, sequential - Product Code NXC
ProductClarity 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
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
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5w-06
Saint Paul MN 55144-0001
For Additional Information ContactLissa Reitz
651-733-1110
Manufacturer Reason
for Recall		Attachments may not mate with the tooth as intended in the digital treatment design.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionOn November 22, 2024, the firm notified customers via URGENT Product Recall letters. Customers were informed that select grip attachments were impacted by a software nonconformance, limited to the lower arch of specific dual-arch Clarity Precision Grip Attachment orders. The firm advises that customers not use products from the identified Case IDs, and that they should dispose of affected products. Customers should complete and return the included customer product destruction form. The firm will provide replacement product. If you have additional questions or need to report an adverse event, contact the Clinician Support team (800-423-4588, option 2) or customortho@solventum.com.
Quantity in Commerce171 orders
DistributionProduct was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NXC
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