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Medical Device Recalls Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Gillette Announces Recall of Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills

Dear Consumers:

We want to inform you about reports we have received concerning instances where the brush head of an Oral-B CrossAction Power or PowerMAX toothbrush has become loose in the mouth during brushing.

A. Special Instructions to Caregivers
There have been three reported incidents that occurred while consumers were using our Oral-B CrossAction Power and PowerMAX toothbrushes and refills to assist in brushing the teeth of persons with special needs, such as cerebral palsy or autism. During brushing, the head of the toothbrush became unlatched, and the loose brush head was caught in the throat or swallowed. This may have occurred when the release latch was bitten or hit by front teeth. None of the consumers suffered any permanent injury, but medical assistance was required.

We therefore recommend that consumers stop using the CrossAction Power or PowerMAX toothbrushes and brush refills to assist in brushing the teeth of people with special needs. No other Oral-B product is affected.

If you are currently using a CrossAction Power or PowerMAX to assist in brushing the teeth of a person with special needs, Oral-B will replace it -- at no charge -- with our Oral-B Advance Power 400, which is better suited for use in assisted-brushing environments because it has a brush head without a latch.

Please call 1-800-496-6557 between the hours of 9:00 AM and 5:00 PM (EST) on Monday through Friday and Oral-B will send you a prepaid mailing envelope to return your CrossAction Power or PowerMAX toothbrush to us. Once received, we will send you an Oral-B Advance Power 400 battery toothbrush.

Also, caregivers can find helpful information about brushing the teeth of people with special needs on the website of the American Dental Association:

http://www.ada.org/public/topics/special_needs.asp

B. Information for Other Consumers
In addition, among consumers without special needs, there have been a small number of reports of brush heads being loose in the mouth. None of these consumers swallowed the brush head, no medical assistance was needed, and there were no reports of any permanent injury. We recommend that all consumers use care not to bite down on the brush head during brushing.

C. General Information
Gillette is redesigning the brush heads for these toothbrushes to eliminate issues related to the unlatching of the brush head. The new brush head refills, when available, will fit into the current CrossAction Power and PowerMAX toothbrushes. The new Oral-B CrossAction Power and CrossAction PowerMAX toothbrushes and brush refills are scheduled to be available in stores in January 2005.

You can call 1-800-496-6557 as noted above if you have any questions regarding the use of these products or this notice.

Please note that we are taking these actions because consumer safety is the number one concern at Oral-B. This action is being conducted with the knowledge of the U.S. Food and Drug Administration.

Thank you for your continued support of Oral-B products.

Updated October 27, 2004

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