3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of orthodontic attachments with a design defect affecting proper mating. Though no illnesses or injuries are reported, the product poses a risk of harm due to improper fitting. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' which caps the score at 3.
Plain-English summary
3M Company is recalling Clarity Precision Grip Attachments used in orthodontic treatment. The attachments may not mate properly with the tooth as intended in the digital treatment design.
The recalled attachments are identified by part numbers 359-830 through 359-837. The recall affects 171 orders distributed in the United States, Canada, Australia, and New Zealand.
Consumers and orthodontists should consult with their orthodontist regarding any potentially affected attachments for guidance on next steps.
The recalled product
- 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
- Manufacturer
- 3M Company - Health Care Business
- Category
- Medical Device — Orthodontics
- Affected units
- 171
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 359-831/ 00652221307293
- 359-832/00652221307309
- 359-833/ 00652221307316
- 359-834/ 00652221307361
- 359-835/ 00652221307378
- 359-836/ 00652221307385
- 359-837/ 00652221307392
Distribution
Distributed nationwide across the United States.
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