Mesh, Surgical, Metal
General, Plastic Surgery · 21 CFR 878.3300
Recent MDR events
198 adverse event reports on file
- PYRAMESH® C TITANIUM MESHMay 26, 2025MalfunctionMedtronic Medical Costa Rica S.r.l.3014725904-2025-00109
- UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESHJun 4, 2024InjuryMedos International Sã rl Ch1526439-2024-01625
- UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESHJun 4, 2024MalfunctionMedos International Sã rl Ch1526439-2024-01629
- UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESHJun 4, 2024MalfunctionMedos International Sã rl Ch1526439-2024-01630
- UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESHJun 4, 2024MalfunctionMedos International Sã rl Ch1526439-2024-01632
- CONF PERIMETER MESH KITFeb 7, 2024InjuryDepuy Spine Inc1526439-2024-00853
- UNKNOWN VERTEBRAL BODY REPLACEMENT - MESHSep 28, 2023InjuryMedos International Sã rl Ch1526439-2023-01845
- UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESHJun 5, 2023InjurySynthes Gmbh8030965-2023-07055
- UNK - RESORBABLE IMPLANTS: MESHMar 27, 2023InjurySynthes Gmbh8030965-2023-03691
- UNK - RESORBABLE IMPLANTS: MESHMar 27, 2023InjurySynthes Gmbh8030965-2023-03692
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
32 firms currently registered for this product code
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Medos International Sarl
Le Locle Neuchatel, CH
Depuy Spine, Inc.
RAYNHAM, MA, US
Synthes (usa) Products Llc
West Chester, PA, US
Medtronic Neurosurgery
Fort Worth, TX, US
Lisi Medical Remmele
Big Lake, MN, US
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Jabil Inc. (brandywine)
W Chester, PA, US
Spineology Inc.
Saint Paul, MN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Synthes Gmbh
Zuchwil Solothurn, CH
Paragon Medical Inc.
Castleton, IN, US
Medtronic Puerto Rico Operations Co., Humacao
HUMACAO, PR, US
Medtronic Medical Costa Rica S.r.l.
Coyol Alajuela, CR
Depuy Orthopaedics
BRIDGEWATER, MA, US
Synthes Gmbh
Selzach Solothurn, CH
Tecomet
Woburn, MA, US
Sterigenics Us, Llc
Lewis Center, OH, US
510(k) clearances
12 clearances for this product code
- Anova CorporationAug 13, 2009
K063461 · ANOVA CONTAINMENT DEVICE
- Spineology, Inc.Nov 26, 2003
K014200 · OPTIMESH
- Implex Corp.Oct 2, 2003
K032344 · THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
- Implex Corp.Aug 21, 2003
K032282 · MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
- Macropore Biosurgery, Inc.Jul 1, 2003
K024169 · MACROPORE OS RECONSTRUCTION
- Implex Corp.Feb 19, 2003
K023882 · THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
- Nuvasive, Inc.Jun 13, 2002
K020853 · NUVASIVE MESH
- Synthes (Usa)Dec 18, 1998
K983766 · SYNTHES SYNMESH