Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

202 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Stryker Joint Replacement, RA2024-3598242, Mako Total Knee

    Stryker has discovered specific to the applications listed in Table 1 an increase in the Software Error #3 (SE3) error code when ...

    Waarschuwing | 05-06-2024

  2. Waldemar Link GmbH & Co.KG, R-2024-05, Endo-Model-M & Endo-Model SL (Tibial components)

    There is a risk that the blind screws of the modular tibial component cannot be loosened intraoperatively. This is necessary if ...

    Waarschuwing | 05-06-2024

  3. implantcast GmbH, FSCA_24001, IFU . OPT. MUTARS RS stems and extension pieces

    As part of the certification of the MUTARS RS revision system in accordance with the new European regulation MDR (EU) 2017/745, ...

    Waarschuwing | 03-06-2024

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

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

    Waarschuwing | 28-05-2024

  5. Medtronic Navigation Inc., FA1414, StealthStation® S8 Application - Software App 9735762 Stealth S8 Application

    De StealthStation S8-app wordt gebruikt ter begeleiding van chirurgen bij chirurgisch genavigeerde procedures. Een ...

    Waarschuwing | 24-05-2024

  6. 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

  7. Stryker Joint Replacement, RA2024-3589151, EXETER 2.5 I M PLUG

    Stryker has discovered the potential that the size on the package label of the EXETER 2.5 I M PLUG may not match the device ...

    Waarschuwing | 21-05-2024

  8. Wright Medical Technology, Inc., RA2024-3551148, INFINITY™ RESECTION GUIDE ADJUSTMENT BLOCK

    Stryker has identified an issue that impacts specific lots of Infinity™ Resection Guide Adjustment Blocks. The parts within these ...

    Waarschuwing | 11-04-2024

  9. 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

  10. Mathys Ltd. Bettlach, FSCA24/01, Affinis Inverse Drill bit 2.5, Gen2 and 3.2 Gen2

    Uit ons wereldwijde systeem voor postmarketingcontrole is naar voren gekomen dat enkele Affinis Inverse boorbitten tijdens een ...

    Waarschuwing | 08-04-2024