Recall Z-2326-2016— Mentor Texas, LP.

Name: FDA recall Z-2326-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Mentor Texas, LP., initiated 2016-07-01, terminated 2016-12-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.. Reason: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates..

Recalling firm: Mentor Texas, LP.
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2016-12-09
Firm location: Irving, TX, United States

Product description

Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

Reason for recall

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.