Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. TAG Medical Products Corporation LTD, 8043971-04.23.23-001-R, BETTA LINK SR KNOTLESS IMPLANT KIT

   The drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due ...

   Waarschuwing | 02-06-2023

2. DePuy Mitek, 2244073, Bioknotless Anchor

   This FSN is to alert users that applying bending force and/or bending force with impaction to the BIOKNOTLESS® Anchor Inserter ...

   Waarschuwing | 04-05-2023

3. NuVasive, Inc., BT FSN-2, Precice Bone Transport

   Het Precice Bone Transport System is bedoeld voor verlenging van ledematen, fixatie van open en dichte fracturen, pseudoartrose, ...

   Waarschuwing | 11-04-2023

4. Intuitive Surgical, Inc., ISIFA2022-14-C, da Vinci Xi and da Vinci X Surgical System

   Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat een deel van de instrumentarmen (USM's) van het da Vinci X- en Xi ...

   Waarschuwing | 15-03-2023

5. EUROS, FSN-FSCA-2023-02, NEMOST - Growing Domino - ø 5.5 mm

   Following one customer complaints, we have noted that the locking ring on the notched rod of the NEMOST device was not tight ...

   Waarschuwing | 07-03-2023

6. Johnson & Johnson Surgical Vision, Inc., 2192655 - FSN2022-08, Veritas AI & Fusion Dual Pump Packs

   Johnson & Johnson Vision heeft deze actie in gang gezet ten gevolge van een lasuitsteeksel, de fysieke opening tussen de ...

   Waarschuwing | 23-02-2023

7. Biomet Orthopedic LLC, ZFA2022-00204, Oxford Fixed Lateral

   Biomet Orthopedics LLC is conducting a lot specific medical device Field Safety Corrective Action (removal) for certain Oxford ...

   Waarschuwing | 30-12-2022

8. Safe Orthopaedics, FSN-22-03, CEMENT PUSHER KIT

   Safe Orthopedics has detected an anomaly concerning the instructions for use of the Cement Pushers and Kit Needle kits. The ...

   Waarschuwing | 28-12-2022

9. Zimmer, ZFA2022-00240, NexGen Option Stemmed Tibial Component

   Zimmer, Inc. is conducting a voluntary medical device Field Safety Corrective Action (removal) related to the NexGen® Stemmed ...

   Waarschuwing | 21-12-2022

10. Johnson & Johnson Surgical Vision, 2160299 - FSN2022-03, Veritas Advanced Infusion Packs

    Johnson & Johnson Vision has initiated this Action due to the potential for the irrigation luer to crack or break. A crack or ...

    Waarschuwing | 19-09-2022