CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

Mentor 2" Tall Height TE With Sutures 350cc PN recalled

Mentor Texas is recalling Mentor 2" Tall Height TE With Sutures 350cc PN: 354-9312 The Mentor CPX4 and CPX4 with, distributed nationwide in the US. The recall was initiated on 9 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 6981537

Quantity recalled65 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2747-2016
FDA event ID: 74895
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2016
FDA classified: 7 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: E. coli
Device type: Surgical Instruments

Timeline

9 Aug 2016	Recall initiated by company
7 Sep 2016	Classified by FDA	+29 days
14 Sep 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot 6981537

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 74895

This product is part of a recall event; the main page for the event is Mentor 2" Tall Height TE With Sutures 450cc PN recalled.

Reported	Class	Recall	Company	Reason	Where
14 Sep 2016	CLASS II	Mentor 2" Tall Height TE With Sutures 450cc PN recalled	Mentor Texas	E. coli	Nationwide

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