Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Brainlab AG - Brainlab Cranial Navigation System - Class 1 Recall
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2016 Category: Medical Equipment Source Type: alerts
CompView Medical, LLC - NuCART - Class 2 Recall
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2016 Category: Medical Equipment Source Type: alerts
Brainlab AG - BrainLAB Image Guided Surgery (IGS) System VectorVision fluoro 3D - Class 2 Recall
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2015 Category: Medical Equipment Source Type: alerts
Brainlab AG - VectorVision fluoro 3D - Class 2 Recall
BrainLAB Image Guided Surgery System / Instrument, Stereotaxic. Intended as an intraoperative image-guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2015 Category: Medical Equipment Source Type: alerts
Brainlab AG - Class 2 Recall
The Brainlab Offset Cup Impactor Universal is part of the Brainlab hip system urgery. (a stereotaxic instrument) Product Usage: Usage: The Brainlab hip system is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Brainlab AG - Class 2 Recall
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic...
Source: Medical Device Recalls - August 14, 2014 Category: Medical Equipment Source Type: alerts
Brainlab AG - Spine & Trauma 3D 2.0 - Class 2 Recall
Spine & Trauma 3D 2.0 is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The device enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated...
Source: Medical Device Recalls - April 18, 2014 Category: Medical Equipment Source Type: alerts
Terumo Cardiovascular Systems Corporation - Electrosurgical Cutting and Coagulation Device - Class 2 Recall
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2014 Category: Medical Equipment Source Type: alerts
Brainlab AG - BrainLAB's VectorVision spine - Class 2 Recall
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatom...
Source: Medical Device Recalls - February 11, 2014 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular, LLC - Vasoview Hemopro Endoscopic Vessel Harvesting System - Class 2 Recall
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. ...
Source: Medical Device Recalls - December 7, 2013 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - daVinci TORS Indication of Use - Class 2 Recall
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 30, 2013 Category: Medical Equipment Source Type: alerts
