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U.S. Department of Health and Human Services

Class 2 Device Recall Crest SpinBrush ProWhitening

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  Class 2 Device Recall Crest SpinBrush ProWhitening see related information
Date Initiated by Firm November 11, 2004
Date Posted December 30, 2004
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-0377-05
Recall Event ID 30413
Product Classification Toothbrush, Powered - Product Code JEQ
Product The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening EX Soft Refills, UPC 7 66878 00192 0.
Code Information All Codes.
Recalling Firm/
Manufacturer		 Proctor & Gamble Co
2 Procter And Gamble Plz
Cincinnati OH 45202-3315
For Additional Information Contact John G. Waldmann
513-622-1191
Manufacturer Reason
for Recall		 Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
FDA Determined
Cause 2		 Other
Action The firm notified distributors by letter on November 11, 2004. Distributors are asked to contact all of their retail stores.
Quantity in Commerce 7.5 million toothbrushes and refill heads.
Distribution Nationwide
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.
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