FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissu…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthop…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ABUT GOLD FRICTION-FIT, REF HLA3G
FDA Device · Class II · 2017-10-04 · Zimmer Dental - ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access c…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical ins…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tiss…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orth…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the a…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref
FDA Device · Class II · 2017-10-04 · Novadaq Technologies - UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the…
FDA Device · Class II · 2017-10-04 · Smiths Medical Asd - NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001)…
FDA Device · Class II · 2017-10-04 · Novadaq Technologies - Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
FDA Device · Class II · 2017-10-04 · Zimmer Dental - IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10
FDA Device · Class II · 2017-10-04 · Zimmer Dental - ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A
FDA Device · Class II · 2017-10-04 · Zimmer Dental - Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products - Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical ins…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A
FDA Device · Class II · 2017-10-04 · Zimmer Dental - Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation…
FDA Device · Class II · 2017-10-04 · Fujifilm Medical Systems U - Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgic…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surg…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgi…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
FDA Device · Class II · 2017-10-04 · Deerfield Imaging - ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instru…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthop…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products - Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. ort…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref
FDA Device · Class II · 2017-10-04 · Novadaq Technologies - Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsteril…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surg…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System…
FDA Device · Class II · 2017-10-04 · Medtronic Vascular - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products - Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products - M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgica…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrum…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical inst…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrum…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to a…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgic…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrum…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is…
FDA Device · Class II · 2017-09-27 · Kamiya Biomedical - Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Refer…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation - Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spi…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation - Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Refe…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation - Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spin…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation - Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System
FDA Device · Class II · 2017-09-27 · Medtronic Vascular Galway - VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc
FDA Device · Class II · 2017-09-27 · Biomerieux - AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping
FDA Device · Class II · 2017-09-27 · Beckman Coulter - Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System
FDA Device · Class II · 2017-09-27 · Medtronic Vascular Galway - Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigatio…
FDA Device · Class II · 2017-09-27 · Medtronic Navigation - Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883
FDA Device · Class II · 2017-09-20 · Implant Direct Sybron Manufacturing - Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30
FDA Device · Class II · 2017-09-20 · Beckman Coulter - Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract
FDA Device · Class II · 2017-09-20 · Fujifilm Medical Systems U - Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate…
FDA Device · Class II · 2017-09-20 · Orthofix - Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube sup…
FDA Device · Class II · 2017-09-20 · Toshiba American Medical Systems - Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providi…
FDA Device · Class II · 2017-09-20 · Mako Surgical - Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surg…
FDA Device · Class II · 2017-09-20 · Mako Surgical - Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion
FDA Device · Class I · 2017-09-20 · Leonhard Lang Medizintechnik - Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
FDA Device · Class II · 2017-09-20 · Baxter Healthcare - BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpo…
FDA Device · Class II · 2017-09-20 · Becton Dickinson And - X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-po…
FDA Device · Class II · 2017-09-20 · X Laser - Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and u…
FDA Device · Class II · 2017-09-20 · Fujifilm Medical Systems U - eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) o…
FDA Device · Class II · 2017-09-20 · Biomerieux - Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices…
FDA Device · Class II · 2017-09-20 · Boston Scientific
Other years
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