Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. MEDICREA INTERNATIONAL S.A., FSN-FA1335, GRANVIA-C, IMPIX ALIF, IMPIX ALIF S/A, IMPIX C+. IMPIX DLIF, IMPIX MANTA, IMPIX MANTA+, IMPIX S, IMPIX TLIF, PASS LP

   Tijdens een intern onderzoek ontdekte Medtronic de mogelijkheid van een productconformiteitsprobleem in de vorm van een gaatje in ...

   Waarschuwing | 18-07-2023

2. Stryker Joint Replacement, HRIS ACET CUP CUT TIP

   Stryker has discovered that the HRIS Acetabular Cup Cut Tips may puncture their inner and outer packaging or damage the packaging ...

   Waarschuwing | 22-01-2024

3. SERF, FSN-2021-10, Reusable instruments SERF

   Products delivered by SERF have been cleaned with a washer-disinfector, the automatic cleaning process mentioned in the ...

   Waarschuwing | 20-12-2021

4. Stryker Spine - K2M - Leesburg, FSN-RA2021-2792467, Chesapeake® Anterior Lumbar Removal Tool

   Stryker received reports of a small number of units from one lot of Chesapeake AL Removal Tool, catalog number 2008-90068, ...

   Waarschuwing | 17-09-2021

5. Field Safety Notice: Zimmer Biomet, Various Trauma, Extremities, Hips and Knees Implants

   There is a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and the actual ...

   Waarschuwing | 16-06-2017

6. Smith & Nephew R-2020-14 - POLARSTEM COLLAR Reamer Guide

   Door middel van deze brief delen wij u mee dat Smith & Nephew, Inc. een vrijwillige terugroeping uitvoert van meerdere partijen ...

   Waarschuwing | 22-07-2020

7. Intuitive Surgical, Inc., ISIFA2022-14-C Expansion, a Vinci Xi and da Vinci X Surgical System

   This Field Safety Notice is to notify you that a population of the da Vinci X and Xi system instrument arms (USMs) have ...

   Waarschuwing | 13-11-2023

8. NEWDEAL SAS V-2021-04 - TIBIAXYS Hexalobular T10 Screwdriver

   This letter is to inform you that Smith + Nephew is conducting a voluntary field action for a group of Integra manufactured ...

   Waarschuwing | 31-01-2022

9. Medtronic Xomed, Inc, FSN-FA915, Console IPC-ENT, Master Console EC300, Powerease IPC, Microdebrider M5

   Het doel van deze brief is om u te informeren dat Integrated Power Consoles (IPC's) met softwareversie v2.7.3.0 niet mogen worden ...

   Waarschuwing | 15-06-2020

10. Richard Wolf GmbH, FSN-QM700014400, TUBE SET FOR TEM

    As a result of our continuous product surveillance we became aware of a production-related deficiency in a pump tube comprised in ...

    Waarschuwing | 05-06-2020