Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Swemac Innovation AB, Cannulated Drill for Metacarpal III. Large

   Cannulated diills with an incorrect measuring scale have been released to the market.

   Waarschuwing | 15-01-2025

2. Blue Belt Technologies, Inc, C-2024-03, Real Intelligence Cori

   Klanten ervaren mogelijk wisselend zicht op de REAL INTELLIGENCE-trackerarrays.

   Waarschuwing | 28-05-2024

3. Merit Medical Systems, 1721504-08.23.24-008R, Monarch Inflation

   Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of MONARCH® Inflation Devices due to a packaging ...

   Waarschuwing | 23-09-2024

4. 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

5. 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

6. 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

7. 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

8. DT MedTech, LLC, FSCA-1, Hintermann Series H3 Total Ankle System

   FDA issued a safety communication related to PMA P16036: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected ...

   Waarschuwing | 12-08-2024

9. implantcast GmbH, FSCA 24001,IFU . OPT MUTARS RS stems and extension pieces

   You are receiving this safety information because you have been supplied with one of the above sterns and/or one of the above ...

   Waarschuwing | 24-05-2024

10. 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