CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Clarity Precision Grip Attachments, for use in orthodontic treatment recalled
3M Company - Health Care Business is recalling Clarity Precision Grip Attachments, for use in orthodontic treatment, distributed nationwide in the US. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0743-2025
- FDA event ID
- 95828
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +28 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Attachments may not mate with the tooth as intended in the digital treatment design.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Questions about this recall
Why was it recalled?
Attachments may not mate with the tooth as intended in the digital treatment design.
Which lots are affected?
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
Where was it sold?
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from 3M Company - Health Care Business
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing recalled | 3M Company - Health Care Business | Other | MN |
| Device | CLASS II | 3M Durapore Surgical Tape recalled by 3M Company - Health Care | 3M Company - Health Care Business | Labeling Errors | Nationwide |
| Device | CLASS II | 3M Tube Securement Device, Small/PO x/PO recalled | 3M Company - Health Care Business | Packaging Defects | Nationwide |
| Device | CLASS II | 3M Specialty Blade Assembly recalled by 3M Company - Health Care | 3M Company - Health Care Business | Temperature Abuse | MN |
| Device | CLASS II | 3M Specialty Blade Assembly recalled by 3M Company - Health Care | 3M Company - Health Care Business | Temperature Abuse | MN |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |