Recall Z-0743-2025— 3M Company - Health Care Business

Name: FDA recall Z-0743-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-22

Class II · Ongoing

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2024-11-22. It names one FDA 510(k) clearance: K233257. 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. Reason: Attachments may not mate with the tooth as intended in the digital treatment design..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Ongoing
Initiated: 2024-11-22
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K233257 — 3M ClarityAligners with Quick Attachments3M Company, Unitek Orthodontic Products·cleared 2023-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Attachments may not mate with the tooth as intended in the digital treatment design.

Data sourced from openFDA. This site is unofficial and independent of the FDA.