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Manufacturers
Stryker Australia Pty Ltd
Manufacturer Parent Company (2017)
Stryker
Source
DHTGA
106 Events
Recall of Tritanium PL 6mm
Recall of Mako RIO System Irrigation Clip (partial knee application only)
Recall of QuikFlap Neuro Implants
Recall of LFIT Anatomic CoCr V40 Femoral Head
Recall of Instructions For Use (IFU) - Sonopet Ultrasonic Products
Recall of Power-LOAD (Cot Fastener)
Recall of Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)
Recall of Triathlon TS Tibial Augments Sizes 3 and 6
Recall of LUCAS 2 Chest Compression System
Recall of ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP
Recall of Mako RIO System Ethernet to Fiber Optic Converter
Recall of Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
Recall of Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F
Recall of MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7
Recall of METS Principal Shaft
Recall of rHead Radial Head and Uni-Elbow System
Recall of Thoracic Pedicle Feeler
Recall of Mako THA Application User Guides
Recall of JTS Drive Unit
Recall of Mako Internal cPCI Card Cage
Recall of Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport
Recall of Omega+ Lag Screw Ø13X110MM ST
Recall of Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions
Recall of MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System
Recall of Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm
Recall of K-Wires for T2 and Gamma Systems (Internal fixation wire)
Recall of 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)
Recall of 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)
Recall of STAR Instruments Kit, sterile packaged (used to implant Scandinavian Total Ankle Replacement System)
Recall of LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)
Recall of Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)
Recall of Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)
Recall of Scorpio Patella Clamp (used to hold the patella in place during the cementing process)
Recall of Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)
Recall of Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)
Recall of Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)
Recall of Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)
Recall of PowerPro Ambulance Cots
Recall of Specialty Size 33mm Reduced Diameter Reaming Cutter
Recall of CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
Recall of PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)
Recall of Guide Wires and K-Wires for T2 and Gamma Nailing Systems
Recall of VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432
Recall of Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems)
Recall of Switch Point Infinity 3 (Operating Room Management System)
Recall of Two and three stage I.V. Poles (used as an optional accessory to a stretcher)
Recall of Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut)
Recall of Exeter Small and Large Tapered Pin Reamer (used as part of the Exeter Procedure Pack)
Recall of Duracon Augments - Tibial Wedge Implants
Recall of PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)
Recall of Base array component of the MAKO RIO Robotic Arm
Recall of ALIQUOT Delivery System Complete Set (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weakened or diminished bone stock)
Recall of Xia 3 Titanium Torque Wrench
Recall of X3 TRIATHLON INSERT CR#2 9MM
Recall of Navigational System II - Cart(Surgical navigation system)
Recall of SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)
Recall of Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system)
Recall of Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
Recall of Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters
Recall of Disposable StrykeFlow Tip(electrosurgical suction tip)
Recall of Teflon Tube T2 Humerus, Sterile
Recall of PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)
Recall of CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)
Recall of Triathlon Distal Capture Assembly
Recall of LFIT V40 Femoral Head
Recall of System 6 Aseptic Battery Kit
Recall of MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)
Recall of Triathlon Tibial Alignment Ankle Clamp EM
Recall of Stryker Laparoscopic Manual Instruments and Accessories
Recall of AVS PL SPACER (Used as an aid in spinal fixation)
Recall of Trident Acetabular System Hemispherical Surgical Protocol & Product Reference Guide
Recall of SwitchPoint Infinity 3 - SPI3 (central point of control and integration of ancillary compatible equipment, audio, video, and data routing )
Recall of Sonopet Console (Ultrasonic Surgical Aspirator System)
Recall of AVS ARIA Implant Inserter
Recall of InTouch Critical Care Bed
Recall of 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)
Recall of 12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)
Recall of Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
Recall of Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
Recall of Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)
Recall of 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)
Recall of Trident Tritanium Acetabular Window Trials Case
Recall of Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)
Recall of 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)
Recall of Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion)
Recall of TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)
Recall of 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)
Recall of 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)
Recall of Stryker Standard Video Cart and Vision Mounting Arm
Recall of OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty components and in guiding the marking of bone before cutting)
Recall of Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triathlon Total Knee Arthroplasty procedure kit)
Recall of OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3))
Recall of Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone)
Recall of Sonopet Console (Ultrasonic Surgical Aspirator System)
Recall of GAMMA3 Long Nail Kit R2.0 LEFT (Intramedullary Nail for fracture fixation)
Recall of T4 Zipper Toga (XL - Tall) (Operating room gown)
Recall of Stryker Suction Irrigation Tips (general purpose irrigation/aspiration units)
Recall of Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system)
Recall of Switch Point Infinity 3 (SPI3) (Computer Interface)
Recall of TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision knee implantation kits)
Recall of Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)
Recall of Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)
Recall of 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
Recall of 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)
Recall of Xia 3 Torque Wrench and Mantis Redux Torque Wrench (Supplied as part of Xia 3 instrument tray)
Recall of 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)
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105 devices in the database
Tritanium PL 6mm
Model / Serial
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)
Model / Serial
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
Model / Serial
QuikFlap Neuro ImplantsMultiple Item NumbersMultiple Lot Numbers ARTG Number: 295882(Stryker Australia - Cranofacial fixation plate, non-biodegradable)
LFIT Anatomic CoCr V40 Femoral Head
Model / Serial
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
Model / Serial
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)
100 more
2 manufacturers with a similar name
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Stryker Australia Pty Ltd
Manufacturer Parent Company (2017)
Stryker
Source
DH
Stryker Australia Pty Ltd
Manufacturer Parent Company (2017)
Stryker
Manufacturers representative
Ets.F.A Kettaneh
Source
RLMPH
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