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. Richard Wolf GmbH, QM700023919, PIEZOWAVE 2 CONTROL UNIT

   Richard Wolf has discovered that a capacitor from a particular production batch may fail after a number of surge voltages in a ...

   Waarschuwing | 17-12-2024

3. Medtronic, FA1459, Sterile Percutaneous Reference Pin

   Medtronic heeft geconstateerd dat bij bepaalde partijen van de percutane pen (zie tabel 1 in bijlage A) is vastgesteld dat de ...

   Waarschuwing | 16-12-2024

4. Medicrea International SAS, FA1444, UNID ROD

   In het bijzonder kunnen bepaalde optionele chirurgische parameters, die als referentie worden verstrekt tijdens chirurgische ...

   Waarschuwing | 13-12-2024

5. Waldemar Link GmbH & Co.KG, R-2024-07, Universal Handle, Stainless Steel, straight

   Due to complaints, we have become aware of problems in relation with the universal handle. In the three most recent complaints ...

   Waarschuwing | 23-09-2024

6. Medtronic Navigation Inc., Software App 9735762 Stealth S8 Application

   Medtronic heeft twee softwareafwijkingen geïdentificeerd in StealthStation™ S8-softwareapplicatieversies 1.3.0 en 1.3.2 die ...

   Waarschuwing | 23-09-2024

7. 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

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. Össur hf, FA240601, Miami Select

   Er is vastgesteld dat de klittenband plakkers die aan de zijkanten van het voorste kraagpaneel zijn bevestigd, in sommige ...

   Waarschuwing | 08-08-2024

10. Zimmer Switzerland Manufacturing GmbH, Biolox Delta Ceramic Femoral Heads

    Zimmer GmbH is conducting a medical device Field Safety Corrective Action (removal) for one batch of the Biolox® delta Ceramic ...

    Waarschuwing | 07-08-2024