Mentor
3041 SKYWAY CIRCLE NORTH, IRVING, TX, US
Registered product codes
8 product codes
Recent MDR events
129,061 on file
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08590
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08595
- MENTOR Smooth Round High ProfileJul 31, 2026Injury1645337-2026-08601
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08603
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08604
- Unknown Gel ImplantsJul 31, 2026Injury1645337-2026-08606
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08607
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08608
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08609
- MENTOR MemoryGel Breast ImplantJul 31, 2026Injury1645337-2026-08610
Recalls
30 on file
- Open, ClassifiedJun 26, 2026
A single lot of expired syringes were distributed due to a distribution system control failure.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - Open, ClassifiedMar 27, 2026
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
View FDA record ↗ - TerminatedMay 11, 2017
Missing Dome Pack accessory.
View FDA record ↗ - TerminatedSep 10, 2016
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
View FDA record ↗
Compliance history
Matched by FEI 1000118360.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.