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Manufacturers
Integra Neurosciences Pty Ltd
Manufacturer Parent Company (2017)
Integra Neurosciences Pty Ltd
Source
DHTGA
17 Events
Recall of Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure)
Recall of CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
Recall of DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)
Recall of NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery)
Recall of PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)
Recall of Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)
Recall of CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
Recall of HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)
Recall of CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
Recall of LED Single Bay Battery Charger, supplied with LED Headlight System
Recall of Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
Recall of Integra Mayfield Ultra 360 Base Unit
Recall of Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor
Recall of ACHILLON Minimally Invasive Achilles Tendon Suture System
Recall of Ventricular Catheter Accessory Kit (used for external cerebrospinal fluid (CSF) drainage)
Recall of Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)
Recall of Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
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17 devices in the database
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during a...
Model / Serial
Integra CT-compatible Intubation Head Ring Assembly (HRAIM), (used to stabilise the head during an imaging procedure) Catalogue Number : HRAIMAll lot numbers ARTG Number: 160533
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
Model / Serial
CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623, C6636All lot numbers affectedARTG Number: 197945
DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Rege...
Model / Serial
DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)Catalogue Numbers: ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391, DURS4591Multiple lots affectedARTG: 158829, 158825 & 158826
Product Classification
Neurological Devices
NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Ne...
Model / Serial
NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery)Catalogue Numbers: PNG130, PNG320, PNG520, PNG620, PNG630, NW320, NW340, NW520, NW540, NW740, NW1040Lot Numbers: 1112378, 1112106, 1112004, 1112030, 1111903, 1111938, 1105268, 1112038, 1111971, 1112104, 1112105, 1112297, 1111853, 1112107ARTG Numbers : 158870 and 158924
Product Classification
Neurological Devices
PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)
Model / Serial
PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)Catalogue number: 500-050, 500-080, 500-150, 500-180, 500-250, 500-280, 500-350, 500-380, 510-111, 510-141, 510-211, 510-241, 510-311, 510-341All batch numbers are affected. ARTG Number: 173962
12 more
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