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U.S. Department of Health and Human Services

Class 2 Device Recall Mentor MemoryGel Breast Implant

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  Class 2 Device Recall Mentor MemoryGel Breast Implant see related information
Date Initiated by Firm July 01, 2016
Create Date August 03, 2016
Recall Status1 Terminated 3 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/
Mentor Texas, LP.
3025 Skyway Cir N
Irving TX 75038-3524
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
FDA Determined
Cause 2
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 and Original Applicant = MENTOR CORP.