Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2098-2012Class II

Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc...

Church & Dwight Co., Inc. / initiated 2011-12-22 / Terminated / root cause: design

Church & Dwight Inc began a recall of Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2098-2012
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Church & Dwight Co., Inc.
Product
Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Product code
JEQ Toothbrush, Powered
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.
Root cause tag
design
FDA root cause
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
0.347 million units
Distribution
Worldwide Distribution.
Product codes and lots
Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094001)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2098-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0857-2012Class IITerminatedVoluntary: Firm initiated
Z-0858-2012Class IITerminatedVoluntary: Firm initiated
Z-0859-2012Class IITerminatedVoluntary: Firm initiated
Z-2093-2012Class IITerminatedVoluntary: Firm initiated
Z-2094-2012Class IITerminatedVoluntary: Firm initiated
Z-2095-2012Class IITerminatedVoluntary: Firm initiated
Z-2096-2012Class IITerminatedVoluntary: Firm initiated
Z-2097-2012Class IITerminatedVoluntary: Firm initiated
Z-2098-2012Class IITerminatedVoluntary: Firm initiated
Z-2099-2012Class IITerminatedVoluntary: Firm initiated