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Sources: EU EUDAMED, US FDA
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Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator, a cannula, and a cannula obturator, which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code NBH·January 6, 2012
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Invacare 2G Tarsys Seating System, Model 2GR.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·December 15, 2003
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·April 30, 2019
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 26, 2019
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Recall
Terminated
·LDR Spine USA, Inc.·Product code LXH·August 29, 2016
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·June 16, 2021
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·June 17, 2020
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019