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Credits
Manufacturers
Synthes Australia Pty Ltd
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
DHTGA
44 Events
Recall of Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
Recall of Bending/Cutting Pliers with Nose, for LOCK Plates 2.0
Recall of Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system
Recall of Synthes Small Electric Drive Hand Piece (Drill Surgical System)
Recall of Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel
Recall of T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
Recall of Anspach Attachments and Handpieces (reusable surgical devices)
Recall of Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)
Recall of Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)
Recall of DCP 2.0, 7 holes, length 37 mm, Stainless Steel, Sterile ( Non-biodegradable orthopaedic fixation plate)
Recall of Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial fixation plate)
Recall of Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large)
Recall of Craniomaxillofacial (CMF) Distraction System (modular family of internal distraction devices to lengthen the mandibular body and ramus) BC Distractor Body, end activated, with Universal Joint for CMF Distractor:Distraction length 15 mm
Recall of SynFix-LR Surgical Implant Holder
Recall of Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)
Recall of Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
Recall of T-Adaptation Plate 1.3, head 3 holes, shaft 8 holes, Stainless Steel, and T-Adaptation Plate 1.3, head 4 holes, shaft 8 holes, Stainless Steel (orthopaedic fixation plates)
Recall of LCP Plate 2.4, straight, 8 holes, length 68 mm, Stainless Steel (fixation plate used to treat orthopaedic fractures)
Recall of LCP Condylar Plate 2.4 Shaft, 7 Hole Head, 2 Hole (fixation plate used to treat orthopaedic fractures)
Recall of Holding Forceps for SynReam Reaming Rod 2.5 mm (used during surgery to retain an instrument, reduce a fracture, spread an osteotomy, or hold an implant in place)
Recall of Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short Attachments
Recall of SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays)
Recall of TomoFix Plate Medial Tibia 4 Hole Standard and TomoFix Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile
Recall of Application Instrument for Sternal ZipFix
Recall of Locking Screw Stardrive 2.4mm and 2.7mm (self-tapping, 12 mm length, stainless steel. Orthopaedic bone screw)
Recall of Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)
Recall of Transpedicular Schanz Screw (Bone screw for internal spinal fixation system)
Recall of Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile
Recall of MIA16 Minimally Invasive Attachment used with the Anspach Product Insert version 18-0074 Rev A 05/12
Recall of Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)
Recall of Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegradable bone screw)
Recall of Guide Wire 2.5mm, with drill tip, length 300mm Cobalt-Chrome Alloy (Orthopaedic fixation nail guidewire)
Recall of Soft Tissue Retractor, small, extendible
Recall of Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, cables and crimps/clamps)
Recall of LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (Orthopaedic fixation plate)
Recall of MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile and sterile screws supplied as part of a craniofacial fixation plate kit)
Recall of Flexible Handle for Simplified Universal Nail System (SUN) and the Universal Nail System (UNI) (Re-usable surgical instrument supplied as part of internal fixation system implantation kit)
Recall of DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length
Recall of Locking screw 3.5mm, self tapping, length 55mm, stainless steel, sterile (Orthopaedic bone screw, non-biodegradable)
Recall of Transpedicular Schanz Screw, 6.2mm with dual core, length 190/45mm. Titanium alloy (TAN), dark blue (Bone screw for internal spinal fixation system)
Recall of Hand Switch for Electric Pen Drive (electrical drive for use with a range of surgical attachments)
Recall of Micro Curved Attachment (MCA) and MCA Cutting Burrs (Intended for use in delicate bone in otologic (ear) procedures such as cochleostomy)
Recall of Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)
Recall of Cancellous Bone Impactor 6.0mm, Flattened (Supplied as part of the bone internal fixation system implantation kit)
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44 devices in the database
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
Model / Serial
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexiblePart Number: 397.232Multiple lot numbers affectedARTG Number: 153950
Bending/Cutting Pliers with Nose, for LOCK Plates 2.0
Model / Serial
Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Part Number: 329.143 Multiple Lot Numbers affectedARTG Number: 153950
Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system
Model / Serial
Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system Part Numbers: 352.260S and 351.718.02S Multiple lot numbers affected ARTG Number:157016
Synthes Small Electric Drive Hand Piece (Drill Surgical System)
Model / Serial
Synthes Small Electric Drive Hand Piece (Drill Surgical System)Part Number: 05.001.175 All Lot NumbersARTG Number: 157072
Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel
Model / Serial
Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel Part Number: 204.828 Lot Numbers: 8573875; 8594066 ARTG Number: 157068
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