CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report

CPX4 Breast Tissue Expander 650 cc recalled by Mentor Texas, LP

Mentor Texas is recalling CPX4 Breast Tissue Expander 650 cc, 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 6947019

Quantity recalled30 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-2781-2016
FDA event ID: 74899
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2016
FDA classified: 9 Sep 2016
Reported: 21 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Breast Implants

Timeline

9 Aug 2016	Recall initiated by company
9 Sep 2016	Classified by FDA	+31 days
21 Sep 2016	Published in enforcement report	+12 days

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

Reason for recall

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

Nationwide

Questions about this recall

Why was it recalled?

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Which lots are affected?

Lot 6947019

Where was it sold?

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

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 74899

Reported	Class	Recall	Company	Reason	Where
21 Sep 2016	CLASS II	Artoura Breast Tissue Expander 700 cc recalled by Mentor Texas, LP	Mentor Texas	Packaging Defects	Nationwide

More recalls from Mentor Texas

All 17

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Syringe Luer Lok 10cc-200/box Bd recalled by Mentor Texas	Mentor Texas	Device Malfunction	CA, FL, PA
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP	Mentor Texas	Device Malfunction	Nationwide

Other Breast Implants recalls

All 29

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	BBraun Medical Winged INF recalled	B Braun Medical	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun Winged Infusion, Single PK recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide