MENTOR MemoryGel Resterilizable Gel Sizer RSZ2001SRecalls & reported problems
Mentor Texas L.P. · Moderate Plus Profile, M+ 200cc Gel Sizer · Class U
All models of MENTOR MemoryGel Breast Implants (368)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317007487), received between May 16, 2023 and May 16, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Reprocessing 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Reprocessing Problem1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2023Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem; Device Reprocessing Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO FEMALE PATIENTS UNDERWENT UNSPECIFIED BREAST SURGERIES WITH A MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER AND MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER AND EXPERIENCED INFECTIONS POSTOPERATIVELY. PER THE PHYSICIAN, THE SIZERS WERE FOUND TO HAVE A RESIDUE ON THEM POST-STERILIZATION. IT IS NOT KNOWN CONCLUSIVELY IF THE INFECTIONS ARE RELATED TO THE STERILIZATION ISSUES, BUT THESE EVENTS ARE BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THIS REPORT IS FOR THE FIRST OF THE TWO DEVICES.
Patient problems: Post Operative Wound Infection
MAUDE report 16943203 ↗
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 · TerminatedMENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Other SIZER, MAMMARY, BREAST IMPLANT VOLUME devices
- Natrelle INSPIRA Resterilizable Sizers MSZ-F450Allergan, Inc. · Mammary Sizer6 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F385Allergan, Inc. · Mammary Sizer4 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F560Allergan, Inc. · Mammary Sizer3 reports
- MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB480SMentor Texas L.P. · SIZER, MAMMARY, BREAST IMPLANT VOLUME3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F335Allergan, Inc. · Mammary Sizer3 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F295Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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