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MENTOR Smooth Round High Profile Saline Breast Implant

by Mentor United States EUDAMEDGUDID

Ref 350-3420Model MENTOR Saline-Filled Breast Implants

Product code FWMEMDN P0601010101

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0081317a000043X Basic UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00081317001669 UDI-DIDate17 Sep 2014ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0367-2022 FDA Class II initiated 30 Sep 2021

    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.

    • Terminated Z-2070-2017 FDA Class II initiated 27 Mar 2017

    Missing Dome Pack accessory.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
MENTOR Smooth Round High Profile Saline Breast Implant EUDAMED
MENTOR Smooth Round High Profile GUDID
Generic Name
Saline-filled breast implant, unstructured, smooth-surface
Device Name
MENTOR Saline-Filled Breast Implants
Model / Ref / Catalog
MENTOR Saline-Filled Breast Implants, 350-3420, 3503420
Primary DI / UDI-DI
00081317001669
Basic UDI-DI
0081317a000043X
PMA Number
FDA Product Code
FWM
EMDN Code
P0601010101 Breast implants, round, saline, with smooth surface
GMDN Term
Saline-filled breast implant, unstructured, smooth-surface
Device Class
Class III
Regulation Number
878.3530
Medical Purpose
The intended purpose of the Mentor Saline-Filled Breast Implants is to replace missing breast tissue or to enhance a breast in females undergoing breast augmentation (non-medical) or breast reconstruction (medical purpose)
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MENTOR Saline-Filled Breast Implants
350-3420
GUDID
3503420
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-PR-000013792

Other devices from Mentor Corp.

See all devices from Mentor Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
Other properties (6)
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 10aaaf16-374e-45f0-8293-e53b9291fa46 61 fields · synced 22 Oct 2026
  • FDA UDI 0578e0b1-24a6-42ca-9b5e-b7ff79045f59 36 fields · synced 30 May 2026