Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manu...

FDA Device Recall #Z-0858-2012 - Class II, December 22, 2011

Recall Summary

Recall Number Z-0858-2012
Classification Class II - Moderate risk
Date Initiated December 22, 2011
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Church & Dwight Inc
Location Princeton, NJ
Product Type Devices
Quantity 0.731 million units

Product Description

Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

Reason for Recall

Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.

Distribution Pattern

Worldwide Distribution.

Lot / Code Information

N/A

Other Recalls from Church & Dwight Inc

Recall # Classification Product Date
Z-1350-2023 Class II Easy Read App associated with First Response Pr... Jan 25, 2023
Z-1811-2013 Class II Sodium Bicarbonate, USP Provided bulk as raw ... Jun 11, 2013
Z-2093-2012 Class II Arm and Hammer Spinbrush Pro Clean Sonic Powere... Dec 22, 2011
Z-2094-2012 Class II Arm and Hammer Spinbrush Pro Clean Sonic Color ... Dec 22, 2011
Z-2095-2012 Class II Arm and Hammer Spinbrush Pro White Sonic Crest ... Dec 22, 2011

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.