Class 3 Device Recall Mentor

• Date Initiated by Firm: December 16, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 25, 2004
• Recall Number: Z-0977-04
• Recall Event ID: 29132
• Product Classification: Plastic Surgery And Accessories Kit - Product Code FTN
• Product: Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
• Code Information: Lot numbers 269402 and 264358
• FEI Number: 1000118360
• Recalling Firm/ Manufacturer: Mentor Texas, Inc; 3041 Skyway Cir N; Irving TX 75038-3500
• Manufacturer Reason for Recall: Device was distributed without the dome part accessory, part number 350-DOMPK
• FDA Determined Cause: Other
• Action: The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.
• Quantity in Commerce: 51 units
• Distribution: Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.
• 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.