Z-2326-2016Class II

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

Name: Z-2326-2016 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction
Creator: Mentor Texas, LP.
Published: 2016-07-01
License: https://open.fda.gov/license/

Mentor / initiated 2016-07-01 / Terminated / root cause: labeling and UDI

FDA source

Mentor Texas, LP. began a recall of Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction on 2016-07-01. FDA classified it as Class II and gives the reason as "The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2326-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-08-03
Terminated: 2016-12-09
Recalling firm: Mentor
Product: Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Product code: FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Reason for recall: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: 7316994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2326-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2326-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

Product code FTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)