MENTOR MemoryGel Resterilizable Gel Sizer RSZ3754SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317007791), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K062421); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER 375CC BEING USED IN A PRIMARY BREAST RECONSTRUCTION WAS FOUND TO BE EXPIRED DURING THE OPERATION. IT WAS INDICATED THE DEVICE WAS TEMPORARILY USED ON THE PATIENT. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10339970 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062421. One submission often covers many models, so check the product and lot details in each record.

• Z-0964-2015 · Dec 11, 2014 · Terminated
  MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.