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1,784 recalls
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 7133...
Medical Implants·1,766 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 4...
Medical Implants·1,450 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·58 affected·Apr 22, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System,...
Medical Implants·76 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Stand...
Medical Implants·91 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: ...
Medical Implants·1 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibi...
Medical Implants·11 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vangua...
Medical Implants·105 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Medical Implants·12 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Com...
Medical Implants·54 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prost...
Medical Implants·15 affected·Apr 17, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 1088885...
Medical Implants·211 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
CriticalFDA
Medtronic Inc.
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medical Implants·24 affected·Apr 10, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Medical Implants·2,614 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Medical Implants·2,225 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Medical Implants·85 affected·Apr 3, 2020
High RiskFDA
Boston Scientific
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
Medical Implants·32 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Medical Implants·19 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Medical Implants·50 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Medical Implants·2 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Medical Implants·57 affected·Mar 9, 2020
High RiskFDA
Kerr/pentron, Dba Kerr Corporation And Pentron Clinical
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of th...
Medical Implants·111 affected·Feb 25, 2020
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correc...
Medical Implants·190 affected·Feb 12, 2020
High RiskFDA
Boston Scientific Corporation
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended ...
Medical Implants·4 affected·Feb 12, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medical Implants·23,180 affected·Jan 30, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter i...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter i...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter ...
Medical Implants·39,687 affected·Jan 29, 2020
High RiskFDA
Exactech, Inc.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which pro...
Medical Implants·4 affected·Jan 27, 2020
High RiskFDA
Aesculap Implant Systems Llc
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN...
Medical Implants·24,010 affected·Jan 21, 2020
High RiskFDA
Aesculap Implant Systems Llc
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K N...
Medical Implants·0 affected·Jan 21, 2020