Tecnología Médica
Tecnología Médica
Cannulated Screw System
16/03/2023 -
The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252.
Recall start date:...
Durasul Modular Head
16/03/2023 -
Zimmer Biomet is conducting a medical device correction to update the compatibility matrix as referred to in the instructions for use (IFU) for the CoCr Femoral Head XS. The update is to remove the...
La AEMPS y la SEC lanzan la nueva edición de la Guía para la persona portadora de marcapasos
15/03/2023 -
La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y la Sociedad Española de Cardiología (SEC) han lanzado hoy la nueva edición de la Guía...
Eyecee One Preloaded
13/03/2023 -
Since the end of November 2022, Nidek has received reports from EU countries about elevated intraocular pressure after implantation of Eyecee One Preloaded and Eyecee One Crystal Preloaded. Concerned...
Attune System - Tibial Insert Fixed Bearing Posterior Stabilized
06/03/2023 -
The subject lot was sent for sterilization twice. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the tibial insert material...
Grafton and Grafton Plus Demineralized Bone Matrix
02/03/2023 -
Medtronic is voluntarily recalling specific serial numbers of Grafton™ DMB due to the potential for breach in the sterile barrier. All lots manufactured before November 30 2022 are...
Infinity Occipitocervical Upper Thoracic System Multi Axial Screw
02/03/2023 -
It was identified by Medtronic that an incorrect type of titanium was used for the manufacturing of subcomponents of multi-axial screws that are for use as part of the Infinity oct system. This...
Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers
01/03/2023 -
Learn more about the issue, recommendations, FDA actions and reporting problems to the FDA
Cardiomems Hospital Electronics System
24/02/2023 -
The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have...
Cardiomems Patient and Hospital Electronics System
24/02/2023 -
Abbott has identified that when the Cardiomems Patient Electronics Systems (model CM1100) and Cardiomems Hospital Electronics Systems (HES) (model CM3000) are used to take a reading with the...
Tantalum Bead 1.00mm
23/02/2023 -
The supplied products are not defective but have been exported to Canada without license from Canadian authorities.
Recall start date: February 01, 2023
Transport Strut Hoffmann Lrf
17/02/2023 -
Stryker has identified a nonconformance in specific lots of Hoffmann Lrf bone transport struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the...
Know the risks: Replacing a healthy natural eye lens with an intraocular eye lens for vision correction
06/02/2023 -
Health Canada is warning that intraocular lenses are not licensed to replace a patient’s natural, healthy lens (without cataracts) and that their use for this purpose comes with risks that may...
Hemashield Gold Knitted Graft
02/02/2023 -
Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility...
Permanent Life Support and HLS Sets
25/01/2023 -
Potentially compromised sterile barrier. The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed. Single sterilized and...
Hager & Meisinger GmbH Micro Screw
24/01/2023 -
Non-licensed inventory was sent to Canada via web shop orders starting in February of 2022.
Recall start date: December 12, 2022
Covera™ Vascular Covered Stent
24/01/2023 -
The Covera™ Vascular Covered Stent has the potential to exhibit deployment issues (i.e., failure to deploy the covered stent) due to slide block bond failures in the device handle. Recall...
Biostop G Bioresorbable Cement Restrictor
24/01/2023 -
All lots of Biostop G Bioresorbable Cement Restrictor are being removed as a precautionary measure because recent in vitro testing of endotoxin levels from a sample restrictor fully dissolved in...
Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option
26/12/2022 -
Zimmer Biomet is conducting a medical device recall for Nexgen stemmed cemented option tibial trays due to the clinically and statistically significant higher overall revision rates when these...
Heartware Ventricular Assist System - HVAD Implant Kit
19/12/2022 -
Controller driveline cover of HVAD system may become hardened, creating difficulty or an inability to slide the cover back to access the drive line to control the connector. Access to the...
Evolut Pro+ Transcatheter Aortic Valve
14/12/2022 -
Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on...
