데이터베이스 소개
국제 의료기기 데이터베이스 사용법
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Manufacturers
Synthes Australia Pty Ltd
제조사 모회사 (2017)
Johnson & Johnson
Source
DHTGA
44 Events
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible 의 리콜
Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 의 리콜
Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system 의 리콜
Synthes Small Electric Drive Hand Piece (Drill Surgical System) 의 리콜
Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel 의 리콜
T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) 의 리콜
Anspach Attachments and Handpieces (reusable surgical devices) 의 리콜
Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw) 의 리콜
Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire) 의 리콜
DCP 2.0, 7 holes, length 37 mm, Stainless Steel, Sterile ( Non-biodegradable orthopaedic fixation plate) 의 리콜
Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial fixation plate) 의 리콜
Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large) 의 리콜
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 의 리콜
SynFix-LR Surgical Implant Holder 의 리콜
Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails) 의 리콜
Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling 의 리콜
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) 의 리콜
LCP Plate 2.4, straight, 8 holes, length 68 mm, Stainless Steel (fixation plate used to treat orthopaedic fractures) 의 리콜
LCP Condylar Plate 2.4 Shaft, 7 Hole Head, 2 Hole (fixation plate used to treat orthopaedic fractures) 의 리콜
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) 의 리콜
Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short Attachments 의 리콜
SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays) 의 리콜
TomoFix Plate Medial Tibia 4 Hole Standard and TomoFix Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile 의 리콜
Application Instrument for Sternal ZipFix 의 리콜
Locking Screw Stardrive 2.4mm and 2.7mm (self-tapping, 12 mm length, stainless steel. Orthopaedic bone screw) 의 리콜
Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit) 의 리콜
Transpedicular Schanz Screw (Bone screw for internal spinal fixation system) 의 리콜
Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile 의 리콜
MIA16 Minimally Invasive Attachment used with the Anspach Product Insert version 18-0074 Rev A 05/12 의 리콜
Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV) 의 리콜
Cortex Screw 3.5mm, self-tapping, length 60mm, Stainless Steel, sterile (Orthopaedic non-biodegradable bone screw) 의 리콜
Guide Wire 2.5mm, with drill tip, length 300mm Cobalt-Chrome Alloy (Orthopaedic fixation nail guidewire) 의 리콜
Soft Tissue Retractor, small, extendible 의 리콜
Tensioner (Instrument used for general orthopaedic repairs using implants like cerclage wires, cables and crimps/clamps) 의 리콜
LCP Distal Femoral Plate 4.5/5.0, right, 19 holes, length 436 mm, Titanium Alloy (TAN), sterile (Orthopaedic fixation plate) 의 리콜
MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile and sterile screws supplied as part of a craniofacial fixation plate kit) 의 리콜
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) 의 리콜
DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length 의 리콜
Locking screw 3.5mm, self tapping, length 55mm, stainless steel, sterile (Orthopaedic bone screw, non-biodegradable) 의 리콜
Transpedicular Schanz Screw, 6.2mm with dual core, length 190/45mm. Titanium alloy (TAN), dark blue (Bone screw for internal spinal fixation system) 의 리콜
Hand Switch for Electric Pen Drive (electrical drive for use with a range of surgical attachments) 의 리콜
Micro Curved Attachment (MCA) and MCA Cutting Burrs (Intended for use in delicate bone in otologic (ear) procedures such as cochleostomy) 의 리콜
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) 의 리콜
Cancellous Bone Impactor 6.0mm, Flattened (Supplied as part of the bone internal fixation system implantation kit) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 44 건
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
모델명 / 제조번호(시리얼번호)
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
모델명 / 제조번호(시리얼번호)
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
모델명 / 제조번호(시리얼번호)
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)
모델명 / 제조번호(시리얼번호)
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
모델명 / 제조번호(시리얼번호)
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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