Class 2 Device Recall Mentor MemoryGel Breast Implant

• Date Initiated by Firm: July 01, 2016
• Create Date: August 03, 2016
• Recall Status: Terminated on December 09, 2016
• Recall Number: Z-2326-2016
• Recall Event ID: 74565
• PMA Number: P030053
• Product Classification: Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR
• Product: Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
• Code Information: 7316994
• Recalling Firm/ Manufacturer: Mentor Texas, LP.; 3025 Skyway Cir N; Irving TX 75038-3524
• For Additional Information Contact: Customer Service; 800-235-5731
• Manufacturer Reason for Recall: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
• FDA Determined Cause: Labeling mix-ups
• Action: The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit.
• Quantity in Commerce: 35 units
• Distribution: Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.
• 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.

• PMA Database: PMAs with Product Code = FTR