Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. AesculapAG, FSN-FSCA254, Unimax

   Aesculap AG meldt Field Safety over Unimax; CE mark was applied without valid declaration of conformity.

   Waarschuwing | 22-03-2021

2. Globus Medical, FSCA-2024-003, Cannula A, 9mm x 250mm, ExcelsiusGPS

   De hulpmiddelen kunnen mogelijk niet goed worden gesteriliseerd vanwege een interne opening die aanwezig kan zijn bij sommige ...

   Waarschuwing | 19-02-2024

3. Zimmer Inc., Zimmer Periarticular Locking Plate System – Distal Lateral Fibula Locking Plate

   This Field Safety Corrective Action is due to a possible thread form issue for the locking holes, resulting that the locking ...

   Waarschuwing | 11-04-2024

4. Waldemar Link GmbH & Co. KG, FSN-R-2020-02, MobileLink Impactor Handle

   The Waldemar Link GmbH & Co. KG is recalling all affected impactor handles of these batches which are available on the market for ...

   Waarschuwing | 12-05-2020

5. Zimmer Inc., ZFA2023-00156, M.L Taper

   The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. There has been ...

   Waarschuwing | 07-08-2023

6. TEQUIR S.L., FSN-TQFSCA21001, TRIAL SPACER

   Tequir is conducting a medical device Field Safety corrective Action (return and device modification) for only one manufactured ...

   Waarschuwing | 16-04-2021

7. Zimmer Switzerland Manufacturing GmbH, ZFA2023-00237, Biolox® Option

   One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length ...

   Waarschuwing | 10-11-2023

8. Tornier FA-TOF-2016-018 - MEIJE DUO femoral stems

   Om aan de criteria van de nieuwe norm ISO 7206-4:2010 te voldoen, en zoals sinds eind 2014 staat aangegeven in de bijsluiter van ...

   Waarschuwing | 01-12-2016

9. KeriMedical SA, FSN-06072022-NCI514, KERILOCK SCREWED SUTUR ANCHOR KITS 2.0 AND 4.0

   We have detected a partial mix-up between batches 20-0629 (2.0) and 20-0631 (4.0) leading toa labelling error. This error is due ...

   Waarschuwing | 21-07-2022

10. Medtronic Navigation Inc., FA1384, Pin, 9733235/9733236, 100MM/150MM, Sterile, Perc Ref

    Medtronic is zich ervan bewust geworden dat bepaalde partijen percutane pennen (zie Tabel 1) een kruispen bevatten waardoor de ...

    Waarschuwing | 19-12-2023