MENTOR Smooth Round Moderate Plus Profile 3502175Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00081317001348), received between Jan 25, 2018 and May 27, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Material Rupture” (26 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P990075); 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.

Recalls naming this device

1. Sep 30, 2021Class IIOpen, Classified

   Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

   Z-0367-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Material Rupture

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC ON THE LEFT, AND 325CC ON THE RIGHT PROSTHESIS DEVELOPED BILATERAL DEFLATIONS POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25306346 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BRAIN FOG, FATIGUE, DEPRESSION, AND ANXIETY. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. THE PATIENT REPORTED SHE DOES NOT HAVE A DEVICE IMPLANTED ON THE RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23466491 ↗
• InjuryApr 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21927468 ↗
• InjuryJan 15, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION IN THE POSTOPERATIVE PERIOD, WHICH WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. CONSEQUENTLY, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21161752 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21138235 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21020681 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21020680 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC ON THE A SIDE, AND 175CC ON THE B SIDE, SILICONE BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH IMPLANTS POSTOPERATIVE. THE HEALTH CARE PROFESSIONAL REPORTED THAT ON THE DAY OF SURGERY WITH THE PATIENT ASLEEP ON THE TABLE, THEY REALIZE THAT J&J CUSTOMER CARE MADE AN ERROR AND ONLY ORDERED 1 IMPLANT OF EACH SIZE - NOT 2 IMPLANTS. SINCE THEY WERE SALINE IMPLANTS AND THE PATIENT ON THE TABLE DECIDED TO PROCEED WITH THE SURGERY AND ADJUST THE SALINE LEVELS TO MAKE THEM LOOK AS EVEN AS POSSIBLE. AFTER THE SURGERY, THE PATIENT NOTIFIED THE MD RIGHT AWAY ABOUT THE ISSUE, TOLD THE PATIENT WHAT HAD HAPPENED, SHE SAID RIGHT AWAY SHOULD FEEL ONE BREAST WAS FIRMER THAN THE OTHER AND WANTED TO WAIT UNTIL 3-MONTH POST OP TO SEE THE RESULTS. IT HAS NOW BEEN 3 MONTHS, AND THE PATIENT IS EXTREMELY UPSET AND UNHAPPY., AND WANTS TO EXPLANT THE IMPLANTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE B SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20836686 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19975801 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 21-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE ON THE RIGHT SIDE, AND WITH 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE ON THE LEFT SIDE AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING FATIGUE, ANXIETY AND DEPRESSION, LEFT BREAST MASS, AUTO IMMUNE, THYROID, LYMPHATIC, AND G.I, ISSUES, NEW SURGEON THINKS SHE HAS BII POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 19546676 ↗
• InjuryMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18848740 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC SALINE PROSTHESIS PLACED EXPERIENCED LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18610707 ↗
• InjuryJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17227289 ↗
• InjuryDec 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION ON THE RIGHT SIDE, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16019286 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED NUMEROUS UNSPECIFIED SYMPTOMS THAT SHE BELIEVES WERE CAUSED BY HER IMPLANTS. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. THE DATE OF EXPLANT WAS PROVIDED TO MENTOR AS AN APPROXIMATION. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12564 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15633008 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED NUMEROUS UNSPECIFIED SYMPTOMS THAT SHE BELIEVES WERE CAUSED BY HER IMPLANTS. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. THE DATE OF EXPLANT WAS PROVIDED TO MENTOR AS AN APPROXIMATION. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12563 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15632986 ↗
• InjuryJul 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14982690 ↗
• InjuryOct 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2021, TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 125CC SALINE PROSTHESES THAT WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB COULD NOT BE MATCHED TO AN EXISTING COMPLAINT FILE. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT. AN EXPLANT DATE OF (B)(6) 2021 WAS PROVIDED. SEE 1645337-2021-12080 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12723217 ↗
• InjuryOct 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2021, TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 125CC SALINE PROSTHESES THAT WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB COULD NOT BE MATCHED TO AN EXISTING COMPLAINT FILE. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT. AN EXPLANT DATE OF (B)(6) 2021 WAS PROVIDED. SEE 1645337-2021-12079 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12722951 ↗
• InjurySep 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. MAMMOGRAM PERFORMED ON UNSPECIFIED DATE INDICATED THE DEFLATION. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION AND THE MAMMOGRAM RESULT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12418973 ↗
• InjurySep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12410004 ↗
• InjuryJul 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 175CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED BY THE PHYSICAL CONSULTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12235463 ↗
• InjuryJun 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 175CC ON THE LEFT SIDE, AND 300CC ON THE RIGHT-SIDE, SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. AS A RESULT, PATIENT UNDERWENT, LEFT MASTOPEXY, AND BILATERAL REMOVAL ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12042423 ↗
• InjuryDec 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH TWO 175CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESES (CATALOG #: 3502175) ON (B)(6) 2021. THE DATE OF EXPLANTATION WAS ESTIMATED BASED ON AVAILABLE INFORMATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11070333 ↗
• InjuryNov 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH 175CC SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10788635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048