Devices

Name Classification Manufacturer Risk Class Country Source
Flocare Gastrotomy Tubes (G-tube) ENFit connector Nutricia Australia Pty Ltd Australia
Flocare Infinity Pump and Infinity Plus Pump (enteral feeding pumps) Nutricia Australia Pty Ltd Australia
Flocare Transition Giving Sets (Enteral feeding tube) Flocare Infinity Pack Giving Set MLL W/O DC – TransitionFlocare Infinity Bottle Giving Set – TransitionFlocare Infinity Pack Giving Set W/O DC & W/O MP - TransitionFlocare Infinity Bottle Giving Set W/O MP – TransitionFlocare Infinity Pack Mobile Giving Set – TransitionFlocare Infinity Pack Mobile Giving Set W/O MP - Transition Nutricia Australia Pty Ltd Australia
Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxinium Femoral Component Journey BCS Tibial InsertAll Batch/Lot Numbers Smith & Nephew Pty Ltd Australia
Visionaire Lightweight Alignment Rod Smith & Nephew Pty Ltd Australia
Polarstem Cardan for 21000438 Smith & Nephew Pty Ltd Australia
D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping Smith & Nephew Pty Ltd Australia
Thin and Radial Osteotome Blades Multiple Products and Model Numbers Smith & Nephew Pty Ltd Australia
Reflection Deadblow Mallet Smith & Nephew Pty Ltd Australia
SMF and MDF Modular Neck Hip Prosthesis Multiple products affected Smith & Nephew Pty Ltd Australia
Biolox Delta Ceramic Hip Components Smith & Nephew Pty Ltd Australia
Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis) Smith & Nephew Pty Ltd Australia
Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT)) Smith & Nephew Pty Ltd Australia
Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery) Smith & Nephew Pty Ltd Australia
Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System) Smith & Nephew Pty Ltd Australia
Twinfix Quick-T Knot Pusher Suture Cutters Smith & Nephew Pty Ltd Australia
Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper Sleeve BIRMINGHAM HIP Modular Head Monoblock 38MM~58MM Smith & Nephew Pty Ltd Australia
Renasys GO External Power Supply Units supplied with Renasys GO NPWT Pumps (Negative Pressure Wound Therapy System) Smith & Nephew Pty Ltd Australia
TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders) Smith & Nephew Pty Ltd Australia
Beaver 4.0mm Banana Blade Smith & Nephew Pty Ltd Australia
METS Modular Tumour System Corin Australia Pty Ltd Australia
BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner Corin Australia Pty Ltd Australia
Trinity Acetabular Shell Corin Australia Pty Ltd Australia
Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirs Actelion Pharmaceuticals Australia Pty Ltd Australia
Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections Actelion Pharmaceuticals Australia Pty Ltd Australia