155 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code JEY·September 3, 2009
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·March 19, 2008
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT*** This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·July 28, 2010
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC 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.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code JEY·June 24, 2015
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
FDA Recall
Terminated
·Synthes, Inc.·Product code JEY·June 18, 2020
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
FDA Recall
Terminated
·Biomet, Inc.·Product code JEY·November 25, 2020
BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·October 6, 2009
2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010