Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
General, Plastic Surgery · 21 CFR 878.3500
Recent MDR events
215 adverse event reports on file
- SU-POR SURGICAL IMPLANTSFeb 4, 2026InjuryPoriferous, Llc3010781616-2026-00034
- SU-POR PATIENT-SPECIFIC IMPLANTSJan 5, 2026MalfunctionPoriferous, Llc3010781616-2025-00131
- SU-POR PATIENT-SPECIFIC IMPLANTSJan 5, 2026InjuryPoriferous, Llc.3010781616-2025-00132
- SU-POR SURGICAL IMPLANTMar 7, 2025InjuryPoriferous, Llc3010781616-2025-00118
- HTR-PEKKNov 18, 2024InjuryOxford Performance Materials, Inc.3009582362-2024-00008
- HTR-PMI 1500889 RT FRTOct 4, 2023InjuryBiomet Microfixation0001032347-2023-00367
- SU-POR SURGICAL IMPLANTSSep 27, 2023InjuryPoriferous, Llc3010781616-2023-00105
- HTR-PEKKFeb 22, 2023MalfunctionOxford Performance Materials, Inc.3009582362-2023-00001
- HTR-PMI 646704 LF FRT PAR TEMPFeb 21, 2022InjuryBiomet Microfixation0001032347-2022-00052
- HTR-PMI 990476 RT FRT TEMP PAROct 27, 2021InjuryBiomet Microfixation0001032347-2021-00496
Event type breakdown
Recalls
9 recall events for this product code
- Matrix Surgical Holdings, LLCTerminatedFeb 28, 2017
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Z-1382-2017 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 12, 2014
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2)
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Z-0975-2014 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedDec 18, 2008
Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101.
Lack of assurance of sterility.
Z-0509-2009 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedDec 18, 2008
Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102.
Lack of assurance of sterility.
Z-0510-2009 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedDec 18, 2008
Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00103.
Lack of assurance of sterility.
Z-0511-2009 · View FDA record ↗ - Stryker Craniomaxillofacial DivisionTerminatedDec 18, 2008
Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104.
Lack of assurance of sterility.
Z-0512-2009 · View FDA record ↗ - Matrix Surgical Holdings, LLCTerminatedUnknown
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweigh
Product mislabeling.
Z-1223-2019 · View FDA record ↗ - Matrix Surgical Holdings, LLCTerminatedUnknown
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweigh
Product mislabeling.
Z-1224-2019 · View FDA record ↗ - Biomet Microfixation, LLCTerminatedUnknown
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.
Potential sterility deficiency.
Z-2751-2016 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Eurofins Infinity Laboratory Group Inc.
San Jose, CA, US
Surgical Technology Laboratories Inc.
Lugoff, SC, US
Biomet Microfixation
Jacksonville, FL, US
Implantech Associates, Inc.
Ventura, CA, US
Longeviti Neuro Solutions
Baltimore, MD, US
Oxford Performance Materials, Inc.
South Windsor, CT, US
Matrix Surgical Holdings, Llc Dba Matrix Surgical Usa
Newnan, GA, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Synthes (usa) Products Llc
West Chester, PA, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Poriferous, Llc
Newnan, GA, US
510(k) clearances
25 clearances for this product code
- Longeviti Neuro Solutions, LLCJul 15, 2021
K211514 · Longeviti PorousFit implant
- Oxford Performance Materials, Inc.Jul 20, 2016
K161052 · OsteoFab Patient Specific Facial Device
- Ceremed , Inc.Jul 14, 2016
K160988 · Biopor, AOC Porous Polyethylene, Cerepor
- Ceremed , Inc.Apr 16, 2015
K141880 · BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
- Oxford Performance MaterialsJul 28, 2014
K133809 · OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
- Poriferous, LLCJun 13, 2014
K140437 · SU-POR SURGICAL IMPLANT
- Matrix Surgical Holdings, LLC/Matrix Surgical USAMay 14, 2014
K133046 · OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
- Matrix Surgical USAJul 31, 2013
K123908 · OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES