🍔 Food 💊 Drugs 🏥 Medical Devices
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Class II

Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Atrium Medical Corporation 20130719 Terminated
Distributed: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
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C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Class II

Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Atrium Medical Corporation 20130719 Terminated
Distributed: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
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C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. Class II

Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Atrium Medical Corporation 20130719 Terminated
Distributed: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
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C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies. Class II

Reason: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Atrium Medical Corporation 20130719 Terminated
Distributed: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
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5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Class II

Reason: DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t

Synthes USA HQ, Inc. 20130605 Terminated
Distributed: Nationwide Distribution.
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Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures. Class II

Reason: The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"

Medtronic Xomed, Inc. 20130709 Terminated
Distributed: Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.
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Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Class I

Reason: Reports of false abnormally high glucose readings from test strips

Nova Biomedical Corporation 20130715 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
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Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Class I

Reason: Reports of false abnormally high glucose readings from test strips

Nova Biomedical Corporation 20130715 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
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Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Class I

Reason: Reports of false abnormally high glucose readings from test strips

Nova Biomedical Corporation 20130715 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
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Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control Class I

Reason: Reports of false abnormally high glucose readings from test strips

Nova Biomedical Corporation 20130715 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
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