Matrix Surgical Holdings, LLC - OmniPore Surgical ImplantsRight - Class 2 Recall
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2019 Category: Medical Devices Source Type: alerts
Matrix Surgical Holdings, LLC - OmniPore Surgical Implants - Class 2 Recall
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2019 Category: Medical Devices Source Type: alerts
Biomet Microfixation, LLC - Hard Tissue Replacement Implants - Class 2 Recall
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts
Synthes (USA) Products LLC - Synthes Low Profile Neuro Plating System - Class 2 Recall
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2016 Category: Medical Equipment Source Type: alerts
Synthes (USA) Products LLC - TI Matrix PreBent Maxillary Plates - Class 2 Recall
TI Matrix Pre-Bent Maxillary Plates; The Synthes MatrixORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children. Specific Indications for Use include: " Fractures of the midface and craniofacial skeleton " LeFort I osteotomies, sagittal split osteotomies, and genioplasties " Orthognatbic surgery including reconstructive procedures and procedures to open the airway (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 29, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm - Class 2 Recall
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR BARRIER Sheets Orbital Floor Implant - Class 2 Recall
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPORTitaniumBarrier (MTB) Right - Class 2 Recall
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR BARRIER Sheets Rectangle - Class 2 Recall
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 5.0mm Acorn Bur - Class 2 Recall
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 5.5mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 1.3mm Wire Pass Drill - Class 2 Recall
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 3.0mm Round Fluted Bur Aggressive - Class 2 Recall
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 6.0mm Zyphr Elite Round Fluted Bur - Class 2 Recall
Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
