Z-2781-2016Class II

CPX4 Breast Tissue Expander 650 cc

Name: Z-2781-2016 CPX4 Breast Tissue Expander 650 cc
Creator: Mentor Texas, LP.
Published: 2016-08-09
License: https://open.fda.gov/license/

Mentor / initiated 2016-08-09 / Terminated / root cause: manufacturing process

FDA source

Mentor Texas, LP. began a recall of CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped... on 2016-08-09. FDA classified it as Class II and gives the reason as "The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2781-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-09-10
Terminated: 2017-03-08
Recalling firm: Mentor
Product: 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.
Product code: LCJ Tissue Expander And Accessories
Reason for recall: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .
Quantity in commerce: 30 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Product codes and lots: Lot 6947019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2781-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2780-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09
Z-2781-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code LCJ

K130813UnclassifiedMentor Cpx 4 Breast Tissue Expanders and Mentor Cpx 4 with Suture Tabs Breast Tissue ExpandersMentor Corp. / cleared 2013-04-11

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)