Device recall: MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue…

Class II FDA enforcement event 74895. Recall start date: 9 Aug 2016. Status in the FDA record: Terminated. Termination date: 8 Mar 2017.

Reason for recall, in the words of FDA

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Mentor Texas, LP. started this device recall on 9 Aug 2016. The firm address in the FDA record is in Irving, TX. FDA put the recall in Class II. FDA event 74895 has 2 product records. The first FDA enforcement report date is 14 Sep 2016. The record gives the status Terminated, with the termination date 8 Mar 2017.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.

Recalling firm

Mentor Texas, LP., Irving, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 74895: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2747-2016	MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.	65 units	Class II	Terminated	14 Sep 2016
Z-2748-2016	MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.	70 units	Class II	Terminated	14 Sep 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Mentor Texas, LP.
Initiated	Product (first record)	Type	Class	Records
28 Apr 2026	SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston	Device	Class II	1
18 Feb 2026	CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissu	Device	Class II	7
30 Sep 2021	MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydi	Device	Class II	1
27 Mar 2017	Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081	Device	Class II	1
9 Aug 2016	Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastec	Device	Class II	2
1 Jul 2016	Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.	Device	Class II	1
11 Dec 2014	MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.	Device	Class II	1
2 Jul 2014	EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380S	Device	Class II	1

Mentor Texas, LP.: all 9 events

Official channels

FDA enforcement report Z-2747-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 74895. https://recallregister.com/fda/ii/74895/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
What quantity of product is in FDA event 74895?: The event has 2 product records. The first record gives this quantity: 65 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.