Events

Recall of Device Recall Arm and Hammer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Church & Dwight Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60853
  • Event Risk Class
    Class 2
  • Event Number
    Z-0857-2012
  • Event Initiated Date
    2011-12-22
  • Event Date Posted
    2012-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106646
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Toothbrush, powered - Product Code JEQ
  • Reason
    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.
  • 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

Device

Device Recall Arm and Hammer
  • Model / Serial
    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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    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.
  • Manufacturer
    Church & Dwight Inc

Manufacturer

Church & Dwight Inc
  • Manufacturer Address
    Church & Dwight Inc, 469 N Harrison St, Princeton NJ 08540-3510
  • Manufacturer Parent Company (2017)
    Church & Dwight Co., Inc.
  • Source
    USFDA