Z-2748-2016Class II

MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast...

Name: Z-2748-2016 MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast...
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 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... on 2016-08-09. FDA classified it as Class II and gives the reason as "Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc". 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-2748-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-09-07
Terminated: 2017-03-08
Recalling firm: Mentor
Product: 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.
Product code: LCJ Tissue Expander And Accessories
Reason for recall: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.
Quantity in commerce: 70 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Product codes and lots: Lot 6981543

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2748-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2747-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07
Z-2748-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

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)