134 results
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Sources: EU EUDAMED, US FDA
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Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-943. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-956. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-750-000. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-061. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-647-000. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-963. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-727-000. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-726-000. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-687-000. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-913. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-071. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-914. Product is used for Orthopedic surgery.
FDA Recall
Terminated
·Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia·Product code MEH·January 11, 2008
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
FDA Recall
Open, Classified
·NuVasive Inc·Product code MQP·November 10, 2022
ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code GCJ·April 1, 2005
Medical Air Compressor Model #8413419
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BTI·January 26, 2007
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Recall
Open, Classified
·Medtronic CoreValve LLC·Product code DTI·January 14, 2020
EVair air compressor, model numbers: M1230849 and M1230847
FDA Recall
Open, Classified
·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTY·November 1, 2010
Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
FDA Recall
Terminated
·Shape Medical Systems, Inc·Product code BTY·December 23, 2014