3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to...

FDA Device Recall #Z-0428-2014 — Class III — June 5, 2013

Recall Summary

Recall Number Z-0428-2014
Classification Class III — Low risk
Date Initiated June 5, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm 3M Company - Health Care Business
Location Saint Paul, MN
Product Type Devices
Quantity 1419 (1325 US, 94 OUS)

Product Description

3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

Reason for Recall

3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.

Distribution Pattern

Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.

Lot / Code Information

Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723

Other Recalls from 3M Company - Health Care Business

Recall # Classification Product Date
Z-0743-2025 Class II Clarity Precision Grip Attachments, for use in ... Nov 22, 2024
Z-0038-2025 Class II 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. S... Aug 14, 2024
Z-1633-2024 Class II 3M Durapore Surgical Tape, Catalog Number 1538-118 Mar 20, 2024
Z-1475-2024 Class II 3M Tube Securement Device, Small, 1.7 IN/PO x 2... Feb 20, 2024
Z-1170-2024 Class II 3M Specialty Blade Assembly, REF 9660,70-2011-8... Jan 12, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.