MENTOR MemoryGel Xtra Resterilizable Gel Sizer RSZSHPX700SRecalls & reported problems
Mentor Texas L.P. · High Profile Xtra, Gel Sizer For Use With SHPX-700 · 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 00081317026334), received between Nov 19, 2019 and Nov 19, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER ON (B)(6) 2019. THE SIZER WAS IMPLANTED WITHOUT ISSUE. HOWEVER, WHEN THE SURGEON TRIED PULLING THE SIZER OUT, THE DEVICE WAS RUPTURED. THE SURGEON HAD TO PULL THE SIZER OUT IN PIECES. AS A RESULT, THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 45 MINUTES AS THE SURGEON HAD TO WASHOUT THE IMPLANT POCKET AND PERFORM A DEBRIDEMENT OF THE LOOSE SILICON. THE PROCURE WAS THEN COMPLETED AS PLANNED. THESE DEVICES ARE NOT SUBJECT TO MEDICAL DEVICE REPORTING REGULATIONS; HOWEVER, MENTOR IS SUBMITTING THIS REPORT DUE TO THE NATURE OF THE EVENT.
Patient problems: No Code Available; Not Applicable
MAUDE report 9344853 ↗
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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