MENTOR MemoryGel Xtra Resterilizable Gel Sizer RSZSHPX465SRecalls & reported problems
Mentor Texas L.P. · High Profile Xtra, Gel Sizer For Use With SHPX-465 · 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 00081317026273), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY AND WAS UNINTENTIONALLY IMPLANTED WITH A RIGHT-SIDED 465CC MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER INSTEAD OF A PERMANENT GEL IMPLANT ON (B)(6) 2025. THE ERROR WAS IDENTIFIED WITH THE PATIENT STILL ON THE OPERATING TABLE. AS A RESULT, THE PATIENT WAS REOPENED AND THE SIZER WAS EXCHANGED FOR A PERMANENT GEL IMPLANT. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058312 ↗
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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