Class 2 Device Recall Crest SpinBrush ProWhitening

• Date Initiated by Firm: November 11, 2004
• Date Posted: December 30, 2004
• Recall Status: Terminated on April 12, 2012
• Recall Number: Z-0378-05
• Recall Event ID: 30413
• Product Classification: Toothbrush, Powered - Product Code JEQ
• Product: The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refills, UPC 7 66878 00194 4.
• 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: 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.