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U.S. Department of Health and Human Services

Class 2 Device Recall Arm and Hammer

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  Class 2 Device Recall Arm and Hammer see related information
Date Initiated by Firm December 22, 2011
Date Posted January 25, 2012
Recall Status1 Terminated 3 on April 14, 2015
Recall Number Z-0857-2012
Recall Event ID 60853
Product Classification Toothbrush, powered - Product Code JEQ
Product Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models.
Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.

For dental health; plaque removal.
Code Information Spinbrush Pro Clean Soft (6687800078) Spinbrush Pro Clean Medium (6687800079) Spinbrush Pro Clean Replacement Head Soft 2 ct (6687800080) Spinbrush Pro Clean Replacement Head Medium 2 ct (6687800081) Spinbrush Pro Clean 3 ct BJs (6687800145) Spinbrush Pro Clean 2 ct (6687800425) Spinbrush Pro Clean Extra Soft 2 ct (6687800433) Spinbrush Pro Clean Combo Pack (6687800461) Spinbrush Pro Clean Value Pack (6687800466) Spinbrush Pro Clean Soft Value Pack (6687800709) Total Spinbrush Pro Clean Spinbrush Pro Recharge Spinbrush Pro Clean Recharge (6687800160) Total Spinbrush
Recalling Firm/
Church & Dwight Inc
469 N Harrison St
Princeton NJ 08540-3510
For Additional Information Contact Mr. Lloyd Moberg, Ph.D.
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action Church & Dwight Co., Inc. proposed a consumer education media campaign starting on December 22, 2011 with the following statement: "Safety Notice: Please remember to replace your brush head after 3 months of use, or if the brush is damaged or the parts become loose. Extended usage, loose parts or excessive wear could lead to brush head breakage, generation of small parts and possible choking hazard. Inspect the brush for loose parts before use." The campaign will be conducted in the following media and anticipate that the combined consumer reach of all of these vehicles to be approximately 144 million people an average of 4 times. - Television campaign will be run during the entire Q1 of 2012 (January -March). -Print ads that will appear in the December 30th issues of People, Star, US Weekly and Entertainment Weekly. -Church & Dwight Website will contain the Safety Alert notice starting December 22nd. (www.spinbrush.com) Consumer Relations IVR (Interactive Voice Response) to consumers calling the Spinbrush toll-free numbers). (800-353-3384 and 800-5610752). 4-30-12 1) A print advertisement (Attachment A) containing the Sonic Safety Notice that will appear in each magazine (Star, People, US Weekly, and Entertainment Weekly) as noted: Five total print insertions are planned (on sale dates listed): I. 4/30 -Star 2. 5/14 -Us Weekly 3. 5/28 -People 4. 6/11 -Entertainment Weekly 5. 6/25 -Star 2) A disk containing the 15 second commercial containing the safety notice. 3) A document (Attachment B) of the National TV slots showing when the commercials will run in the quarter, and another with the shows during which they will air. TV ads will begin running the week of April 16th. The DRTV schedule is determined weekly and we are informed after the fact when the ads where shown. The DRTV stations are included at the bottom of the National TV listing. " In total, combined print and TV are estimated to reach 163MM impressions (measurement target: women
Quantity in Commerce 22.783 million units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.