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1,784 recalls
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lippe...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Li...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Medical Implants·30 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Medical Implants·29 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 De...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Line...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Tornier S.a.s.
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm E...
Medical Implants·6,631 affected·Jun 25, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166E...
Medical Implants·18 affected·Jun 7, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125
Medical Implants·4,078 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153
Medical Implants·163 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103
Medical Implants·647 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104
Medical Implants·943 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP
Medical Implants·63 affected·Jun 3, 2021
High RiskFDA
Heartware, Inc.
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory ...
Medical Implants·1 affected·May 28, 2021
High RiskFDA
Tornier, Inc
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Marti...
Medical Implants·20 affected·May 28, 2021
High RiskFDA
Smith & Nephew, Inc.
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, F...
Medical Implants·5 affected·May 19, 2021
High RiskFDA
K2m, Inc
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices in...
Medical Implants·3 affected·May 7, 2021
High RiskFDA
K2m, Inc
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices in...
Medical Implants·7 affected·May 7, 2021
High RiskFDA
Corin Ltd
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Medical Implants·4 affected·May 6, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Medical Implants·3 affected·Apr 28, 2021
High RiskFDA
Willowwood Global Llc
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expu...
Medical Implants·815 affected·Apr 20, 2021
CriticalFDA
Boston Scientific Corporation
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Medical Implants·550 affected·Apr 12, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medical Implants·16,311 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also prov...
Medical Implants·575,815 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 ...
Medical Implants·45,411 affected·Apr 6, 2021
High RiskFDA
W.l. Gore & Associates, Inc.
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040,...
Medical Implants·61 affected·Apr 5, 2021
High RiskFDA
Nobel Biocare Procera Llc
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthe...
Medical Implants·1 affected·Mar 29, 2021
High RiskFDA
Nobel Biocare Procera Llc
NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthe...
Medical Implants·1 affected·Mar 29, 2021
High RiskFDA
Boston Scientific Corporation
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consi...
Medical Implants·23 affected·Mar 26, 2021
High RiskFDA
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 008...
Medical Implants·2,194 affected·Mar 25, 2021
High RiskFDA
Medtronic Neuromodulation
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with...
Medical Implants·79,616 affected·Mar 25, 2021
High RiskFDA
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 008...
Medical Implants·189 affected·Mar 25, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F ...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATI...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION ...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATI...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F ...
Medical Implants·0 affected·Mar 19, 2021