Food, drugs, devices › 3M Company - Health Care Business
Device recall: Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833
FDA enforcement event 95828 is a device recall by 3M Company - Health Care Business of Saint Paul, MN, initiated 22 Nov 2024 and classified Class II, with 1 product record.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. 3M Company - Health Care Business has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
3M Company - Health Care Business, Saint Paul, MN.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0743-2025 | 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 | 171 orders | Class II | Ongoing | 1 Jan 2025 |
Context
Other enforcement events for 3M Company - Health Care Business
All 29 events for 3M Company - Health Care Business
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Attachments may not mate with the tooth as intended in the digital treatment design."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.