Z-0977-04

Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas

Name: Z-0977-04 Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
Creator: Mentor Texas, Inc
Published: 2003-12-16
License: https://open.fda.gov/license/

Mentor / initiated 2003-12-16 / Terminated

FDA source

Mentor Texas, Inc began a recall of Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas on 2003-12-16. The reason FDA records is "Device was distributed without the dome part accessory, part number 350-DOMPK". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0977-04
Status: Terminated
Initiated: 2003-12-16
Posted: 2004-07-20
Terminated: 2004-05-25
Recalling firm: Mentor
Product: Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas
Product code: FTN Plastic Surgery And Accessories Kit
Reason for recall: Device was distributed without the dome part accessory, part number 350-DOMPK
FDA root cause: Other
Action: The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.
Quantity in commerce: 51 units
Distribution: Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.
Product codes and lots: Lot numbers 269402 and 264358

Product code FTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)