Devices

Name Classification Manufacturer Risk Class Country Source
Segmental System Proximal Femoral Component 38mm Offset Zimmer Biomet Pty Ltd Australia
Various ZNN & M/DN Guide Wires Zimmer Biomet Pty Ltd Australia
EBI OsteoGen Implantable Bone Growth Stimulator Zimmer Biomet Pty Ltd Australia
TunneLoc Tibial Fixation Devices (used during anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction) Zimmer Biomet Pty Ltd Australia
A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems Zimmer Biomet Pty Ltd Australia
Vanguard Open Box Posterior Stabilised Femoral Components Zimmer Biomet Pty Ltd Australia
Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades) Zimmer Biomet Pty Ltd Australia
Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire Zimmer Biomet Pty Ltd Australia
Comprehensive Nano Humeral Component PPS Zimmer Biomet Pty Ltd Australia
Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIV Zimmer Biomet Pty Ltd Australia
Affixus Hip Fracture Nail Zimmer Biomet Pty Ltd Australia
iASSIST Validation Tool Zimmer Biomet Pty Ltd Australia
Various Polyethylene Implants Orthopedic Devices Zimmer Biomet Pty Ltd Australia
Vanguard Open Box Femoral Components Zimmer Biomet Pty Ltd Australia
Comprehensive Reverse Shoulder Tray Zimmer Biomet Pty Ltd Australia
Greatbatch Medical Offset Reamer Handle (used in total hip arthroplasty as interface between surgical drill and acetabular reamer) Zimmer Biomet Pty Ltd Australia
Optipac Bone Cement Zimmer Biomet Pty Ltd Australia
Wallis Posterior Dynamic Stabilisation System instruments and containers Zimmer Biomet Pty Ltd Australia
Pressure Care Medical Mattresses and Mattress Covers Australian Comfort Group Australia
EZ-Load Lens Delivery System Ophthalmic Devices iNova Pharmaceuticals Australia Pty Ltd Australia
LaserEdge Knives Ophthalmic Devices iNova Pharmaceuticals Australia Pty Ltd Australia
Algerbrush II and Algerbrush II Accessories Algerbrush – II Rust Ring 0.5mm instrument and Rust Ring 1.0mm instrument Algerbrush – II Accessories0.5mm Burr/Chuck and 1.0mm Burr/Chuck Ophthalmic Devices iNova Pharmaceuticals Australia Pty Ltd Australia
EasySept HYDRO+ (3% hydrogen peroxide) Cleaning & Disinfecting Solution (Contact lens care kit) Affected Products :EasySept HYDRO + Duo Pack 480 mL EasySept HYDRO+ Value Pack 840 mL Easy Sept HYDRO + Starter Kit 120 mL iNova Pharmaceuticals Australia Pty Ltd Australia
Supergloves Vinyl Examination Gloves, powdered & powder free Supergloves Australia Pty Ltd Australia
Deluxe First Aid Kit Uniwide Australia Import Export Pty Ltd Australia