MENTOR MemoryGel Xtra Resterilizable Gel Sizer RSZSHPX450SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317026266), received between Mar 13, 2019 and Mar 13, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6) FEMALE HAD TWO 450CC MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZERS ERRONEOUSLY IMPLANTED. THE SCRUB NURSE HANDED THE PHYSICIAN BRAND NEW STERILE RE-STERILIZABLE GEL SIZERS DURING SURGERY THAT WERE MISTAKENLY IMPLANTED INTO THE PATIENT. THE PATIENT UNDERWENT EXPLANTATION OF THE SIZERS. THE PHYSICIAN EXPRESSED THAT THE DIFFERENCE IN SUPERFICIAL PACKAGING AND APPEARANCE OF THE SIZERS AND IMPLANTS WERE NOT IMMEDIATELY OBVIOUS TO HER. PICTURES OF THE EXPLANTED SIZERS WERE RECEIVED FROM THE CUSTOMER, AND THE SIZERS WERE MARKED, "NOT FOR IMPLANT". THIS IS OFF LABEL USE OF THE PRODUCT. NO MENTOR REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. NO PATIENT CONSEQUENCE, WITH EXCEPTION TO EXPLANTATION PROCEDURE, WAS REPORTED. SEE 3006942524-2019-00505 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8418841 ↗
• InjuryMar 13, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE HAD TWO 450 CC MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZERS ERRONEOUSLY IMPLANTED. THE SCRUB NURSE HANDED THE PHYSICIAN BRAND NEW STERILE RE-STERILIZABLE GEL SIZERS DURING SURGERY THAT WERE MISTAKENLY IMPLANTED INTO THE PATIENT. THE PATIENT UNDERWENT EXPLANTATION OF THE SIZERS. THE PHYSICIAN EXPRESSED THAT THE DIFFERENCE IN SUPERFICIAL PACKAGING AND APPEARANCE OF THE SIZERS AND IMPLANTS WERE NOT IMMEDIATELY OBVIOUS TO HER. PICTURES OF THE EXPLANTED SIZERS WERE RECEIVED FROM THE CUSTOMER, AND THE SIZERS WERE MARKED, "NOT FOR IMPLANT". THIS IS OFF LABEL USE OF THE PRODUCT. NO MENTOR REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. NO PATIENT CONSEQUENCE, WITH EXCEPTION TO EXPLANTATION PROCEDURE, WAS REPORTED. SEE 3006942524-2019-00506 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8418839 ↗

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.