3M Company - Health Care Business recalls Clarity Precision Grip Attachments
Reason for recall
Attachments may not mate with the tooth as intended in the digital treatment design.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 359-830/ 00652221307286; 359-831/ 00652221307293; 359-832/00652221307309; 359-833/ 00652221307316; 359-834/ 00652221307361; 359-835/ 00652221307378; 359-836/ 00652221307385; 359-837/ 00652221307392
What the firm is doing
On 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.
DistributionShow detailsHide
Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0743-2025
- FDA 510(k) clearance · K233257The device's official FDA premarket clearance record
- FDA device classification · NXCOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.5470The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find 3M Company - Health Care BusinessSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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