MENTOR MemoryGel Resterilizable Gel Sizer RSZ3001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317007524), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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.

• MalfunctionDec 2, 2020Material Discolored; Material Discolored

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY USED A MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER 300CC MGEL SIZER EXPERIENCED DISCOLORATION OF THE DEVICE BEFORE THE PROCEDURE. THE PHYSICIAN STATED THAT THE SIZER WAS IN CONTACT WITH THE PATIENT BUT THE PATIENT WASN'T IN THE OPERATING ROOM TO PROVIDE ANY MORE INFORMATION. THE PHYSICIAN INDICATED THAT THE GEL SIZER STARTING TO TURN A DIFFERENT COLOR. FIRST IT WAS LIKE A TAN LIGHT GOLDEN COLOR ONCE IT WAS OPENED FROM THE PACKAGING THEN AFTER STERILIZING IT'S A DIFFERENT COLOR AND HE JUST WANTS TO KNOW IF HE CAN USE IT AGAIN AND IF THE COLOR IS NORMAL. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS CASE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936254 ↗

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.