320 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009
***REF MCA5-05SD, QTY: 1***0.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** ***REF MCA7-05SD, QTY: 1***0.5 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** Cutting and Shaping bone including bones of the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·October 13, 2010
***REF MCA5-15SD, QTY: 1***1.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** ***REF MCA7-15SD, QTY: 1***1.5 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** Cutting and Shaping bone including bones of the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·October 13, 2010
ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·November 28, 2012
Lindemann Drill Short, 1.6mm 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.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·May 22, 2014
Stryker 6.0mm 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.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·May 22, 2014
Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-140.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Stryker 3.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-30.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-70-31.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-60.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HBE·November 30, 2010
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HBE·November 30, 2010
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HBE·November 30, 2010
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·March 29, 2012
ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
5.0mm Round Fluted Bur, Super Long
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBE·June 16, 2016