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Manufacturers
Stryker Australia Pty Ltd
제조사 모회사 (2017)
Stryker
Source
DHTGA
106 Events
Tritanium PL 6mm 의 리콜
Mako RIO System Irrigation Clip (partial knee application only) 의 리콜
QuikFlap Neuro Implants 의 리콜
LFIT Anatomic CoCr V40 Femoral Head 의 리콜
Instructions For Use (IFU) - Sonopet Ultrasonic Products 의 리콜
Power-LOAD (Cot Fastener) 의 리콜
Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System) 의 리콜
Triathlon TS Tibial Augments Sizes 3 and 6 의 리콜
LUCAS 2 Chest Compression System 의 리콜
ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP 의 리콜
Mako RIO System Ethernet to Fiber Optic Converter 의 리콜
Custom Made Implant Systems with Minimally Invasive Grower (MIG) component 의 리콜
Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F 의 리콜
MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7 의 리콜
METS Principal Shaft 의 리콜
rHead Radial Head and Uni-Elbow System 의 리콜
Thoracic Pedicle Feeler 의 리콜
Mako THA Application User Guides 의 리콜
JTS Drive Unit 의 리콜
Mako Internal cPCI Card Cage 의 리콜
Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport 의 리콜
Omega+ Lag Screw Ø13X110MM ST 의 리콜
Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions 의 리콜
MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System 의 리콜
Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm 의 리콜
K-Wires for T2 and Gamma Systems (Internal fixation wire) 의 리콜
Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures) 의 리콜
Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty) 의 리콜
STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System) 의 리콜
LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures) 의 리콜
Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty) 의 리콜
Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures) 의 리콜
Scorpio Patella Clamp (used to hold the patella in place during the cementing process) 의 리콜
Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system) 의 리콜
Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements) 의 리콜
Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty) 의 리콜
Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels) 의 리콜
PowerPro Ambulance Cots 의 리콜
Specialty Size 33mm Reduced Diameter Reaming Cutter 의 리콜
CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone) 의 리콜
PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy) 의 리콜
Guide Wires and K-Wires for T2 and Gamma Nailing Systems 의 리콜
VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432 의 리콜
Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems) 의 리콜
Switch Point Infinity 3 (Operating Room Management System) 의 리콜
Two and three stage I.V. Poles (used as an optional accessory to a stretcher) 의 리콜
Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut) 의 리콜
Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack) 의 리콜
Duracon Augments - Tibial Wedge Implants 의 리콜
PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads) 의 리콜
Base array component of the MAKO RIO Robotic Arm 의 리콜
ALIQUOT Delivery System Complete Set (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weakened or diminished bone stock) 의 리콜
Xia 3 Titanium Torque Wrench 의 리콜
X3 TRIATHLON INSERT CR#2 9MM 의 리콜
Navigational System II - Cart(Surgical navigation system) 의 리콜
SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode) 의 리콜
Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system) 의 리콜
Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants) 의 리콜
Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters 의 리콜
Disposable StrykeFlow Tip(electrosurgical suction tip) 의 리콜
Teflon Tube T2 Humerus, Sterile 의 리콜
PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed) 의 리콜
CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10) 의 리콜
Triathlon Distal Capture Assembly 의 리콜
LFIT V40 Femoral Head 의 리콜
System 6 Aseptic Battery Kit 의 리콜
MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.) 의 리콜
Triathlon Tibial Alignment Ankle Clamp EM 의 리콜
Stryker Laparoscopic Manual Instruments and Accessories 의 리콜
AVS PL SPACER (Used as an aid in spinal fixation) 의 리콜
Trident Acetabular System Hemispherical Surgical Protocol & Product Reference Guide 의 리콜
SwitchPoint Infinity 3 - SPI3 (central point of control and integration of ancillary compatible equipment, audio, video, and data routing ) 의 리콜
Sonopet Console (Ultrasonic Surgical Aspirator System) 의 리콜
AVS ARIA Implant Inserter 의 리콜
InTouch Critical Care Bed 의 리콜
5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal) 의 리콜
12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line) 의 리콜
Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors) 의 리콜
Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors) 의 리콜
Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system) 의 리콜
Xia 3 Titanium Torque Wrench, Mantis Redux Torque Wrench & Xia Torque Wrench (used for final tightening of the blocker on the head of the pedicle screw during posterior spinal fusion surgery) 의 리콜
Trident Tritanium Acetabular Window Trials Case 의 리콜
Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set) 의 리콜
Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms) 의 리콜
Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion) 의 리콜
TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue) 의 리콜
ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems) 의 리콜
Xia 3 Titanium Torque Wrench & Xia 3 Titanium Torque Wrench Short (used for final tightening of the blocker on the head of the pedicle screw during posterior spinal fusion surgery) 의 리콜
Stryker Standard Video Cart and Vision Mounting Arm 의 리콜
OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty components and in guiding the marking of bone before cutting) 의 리콜
Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triathlon Total Knee Arthroplasty procedure kit) 의 리콜
OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3)) 의 리콜
Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone) 의 리콜
Sonopet Console (Ultrasonic Surgical Aspirator System) 의 리콜
GAMMA3 Long Nail Kit R2.0 LEFT (Intramedullary Nail for fracture fixation) 의 리콜
T4 Zipper Toga (XL - Tall) (Operating room gown) 의 리콜
Stryker Suction Irrigation Tips (general purpose irrigation/aspiration units) 의 리콜
Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system) 의 리콜
Switch Point Infinity 3 (SPI3) (Computer Interface) 의 리콜
TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision knee implantation kits) 의 리콜
Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit) 의 리콜
Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area) 의 리콜
Triathlon CR/PS Inserts & ASYM Patella, Brunswik Captive Cemented Cup, Avon Patella Medium & Patella Femoral Joint, HMRS Humerus Bearing, MRH Bumper Neutral/3 Degrees & Tibial Inserts, Scorpio CR Tibial Insert & Medialised Patella, Duracon PCA Femoral, Patella & Constrain Inserts, Scorpio PS Tibial & Flex PS/+PS/+PCS Inserts (total knee, hip, shoulder components) and Artisan Bone Plug 의 리콜
6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to use a cluster/multi-hole shell in the acetabulum prosthetic component) 의 리콜
Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray) 의 리콜
ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 105 건
Tritanium PL 6mm
모델명 / 제조번호(시리얼번호)
Tritanium PL 6mm Item Numbers:48950066 & 48954066Lot Numbers: A8AM, A8T2ARTG Number: 265560(Stryker Australia Pty Ltd - Spinal cage)
Mako RIO System Irrigation Clip (partial knee application only)
모델명 / 제조번호(시리얼번호)
Mako RIO System Irrigation Clip (partial knee application only)Catalogue Number: 111690Lot Numbers: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643 and 195763A1ARTG Number: 223929
QuikFlap Neuro Implants
모델명 / 제조번호(시리얼번호)
QuikFlap Neuro ImplantsMultiple Item NumbersMultiple Lot Numbers ARTG Number: 295882(Stryker Australia - Cranofacial fixation plate, non-biodegradable)
LFIT Anatomic CoCr V40 Femoral Head
모델명 / 제조번호(시리얼번호)
LFIT Anatomic CoCr V40 Femoral Head Item Numbers: 6260-9-036, 6260-9-040, 6260-9-044, 6260-9-136, 6260-9-140, 6260-9-144, 6260-9-336, 6260-9-236Head Diameters: 36mm, 40mm and 44mmMultiple Lot NumbersARTG Number: 211868 (Stryker Australia Pty Ltd - LFIT V40 FEMORAL HEAD - Metallic femoral head prosthesis)
Instructions For Use (IFU) - Sonopet Ultrasonic Products
모델명 / 제조번호(시리얼번호)
Instructions For Use (IFU) - Sonopet Ultrasonic ProductsMultiple affected productsARTG numbers:174349 (Stryker Australia - Electrosurgical unit, ultrasonic/mechanical vibration)297743 (Stryker Australia Pty Ltd - Ultrasonic surgical system torque wrench, reusable)298249 (Stryker Australia - Electrode handpiece, electrosurgical, ultrasonic/mechanical vibration, foot-controlled)
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Stryker Australia Pty Ltd
제조사 모회사 (2017)
Stryker
Source
DH
Stryker Australia Pty Ltd
제조사 모회사 (2017)
Stryker
제조사 대표
Ets.F.A Kettaneh
Source
RLMPH
Language
English
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