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Manufacturers
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
제조사 모회사 (2017)
Johnson & Johnson
Source
DHTGA
46 Events
Sciatic Nerve Retractors 의 리콜
SIGMA HP PFJ Cemented Trochlear Implants 의 리콜
DePuy Synthes Confidence Kit Spinal Cement System 의 리콜
Acetabular Cup Introducer (32mm) 의 리콜
DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HA 의 리콜
Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit) 의 리콜
Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile 의 리콜
DePuy Synthes Impactor for PFNA Blade 의 리콜
SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system) 의 리콜
SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system) 의 리콜
Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw) 의 리콜
Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece 의 리콜
Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System 의 리콜
Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System) Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm 의 리콜
Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects) 의 리콜
Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium 의 리콜
Drill Sleeve 9.0/2.8, L 191 mm, f/AFN (used with the Antegrade Femoral Nail System to hold and guide implants and instruments during orthopaedic surgery) 의 리콜
Cranial Screw PlusDrive ø 1.6 mm, Self-Drilling, L 3mm (part of the Low Profile Neuro System intended for use in selective trauma of the midface and craniofacial skeleton) 의 리콜
Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel 의 리콜
Depuy Synthes Universal Battery Charger II (UBC II) 의 리콜
LCP Distal Tibial Plates 3.5 anterolateral, left, 9 holes, length 132mm Stainless Steel Sterile 의 리콜
Extraction Screw for PFNA Blade 의 리콜
PFNA Nails (used during internal fixation surgery) 의 리콜
Synream Medullary Reamer Head Size 13.5mm 의 리콜
PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation surgery) 의 리콜
Kirschner Wire 1.6 mm, with drill tip, length 200 mm 의 리콜
Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery) 의 리콜
Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System 의 리콜
Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system) 의 리콜
Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures) 의 리콜
Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long 의 리콜
Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion) 의 리콜
VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only) 의 리콜
DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm. 의 리콜
Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible) 의 리콜
Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set) 의 리콜
CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery) 의 리콜
TFN-ADVANCED Proximal Femoral Nailing System (TFNA) 의 리콜
Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade(Component of the fixation system implantation kit) 의 리콜
Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue) 의 리콜
Cross-Link Clamp for Rods, 6.0 mm 의 리콜
Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails) 의 리콜
LCS COMPLETE RPS Knee System 의 리콜
Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide) 의 리콜
Inserter f/TEN 의 리콜
DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 46 건
Sciatic Nerve Retractors
모델명 / 제조번호(시리얼번호)
Sciatic Nerve Retractors Part Numbers: 03.100.013, 03.100.014Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369ARTG Number: 296161Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep
SIGMA HP PFJ Cemented Trochlear Implants
모델명 / 제조번호(시리얼번호)
SIGMA HP PFJ Cemented Trochlear ImplantsARTG Number - 270733
DePuy Synthes Confidence Kit Spinal Cement System
모델명 / 제조번호(시리얼번호)
DePuy Synthes Confidence Kit Spinal Cement SystemProduct Number: 283910000Confidence Plus Kit Spinal Cement System, 11ccLot Numbers: 133824, 145665, 145664, 135476, 152906Confidence Kit Spinal Cement SystemLot Numbers: 133831, 145669, 152908, 153883, 154956, 154957ARTG Number: 211565
Acetabular Cup Introducer (32mm)
모델명 / 제조번호(시리얼번호)
Acetabular Cup Introducer (32mm)Product Number: 962636000 Lot Number: 0SA203015ARTG Number: 132270
DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Cent...
모델명 / 제조번호(시리얼번호)
DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HAMultiple Part and Lot NumbersARTG Number: 143529
하나 더 41 건 더
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