Z-2591-2014Class II

EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer...

Name: Z-2591-2014 EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer...
Creator: Mentor Texas, LP.
Published: 2014-07-02
License: https://open.fda.gov/license/

Mentor / initiated 2014-07-02 / Terminated / root cause: labeling and UDI

FDA source

Mentor Texas, LP. began a recall of EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage... on 2014-07-02. FDA classified it as Class II and gives the reason as "The device labeling is stamped with 330cc and the device is actually 380cc device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2591-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-02
Posted: 2014-09-04
Terminated: 2015-04-06
Recalling firm: Mentor
Product: EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Product code: MRD Mammary Sizer
Reason for recall: The device labeling is stamped with 330cc and the device is actually 380cc device.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Mentor sent an Important Customer Notification letter dated July 17, 2014 to all affected customers and follow-up with a visit by the local sales representative. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify all unsused product from lot list provided and maintain a copy of this notice with the affected product. For question contact your local Sales Representative or Mentor Customer Service at 1-800-235-5731.
Quantity in commerce: 34 units
Distribution: U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
Product codes and lots: Part Number (PN) 351-3380SZ Lot Number 6830722

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2591-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code MRD

K010709UnclassifiedMentor Sterile Saline Mammary Volume SizersMentor Corp. / cleared 2001-04-23

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)