Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

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. Update - Medtronic Navigation, Inc., FA1361, Neuroscience CST - StealthStation™ S8 App version 2.0 and 2.0.1

   Medtronic heeft een softwareprobleem geïdentificeerd in de StealthStation™ S8-app, softwareversies 2.0 en 2.0.1 dat kan optreden ...

   Waarschuwing | 09-02-2024

6. Waldemar Link GmbH and Co.KG, R-204-032, SPII Model Lubinus - Hip Prosthesis Stem

   Due to two complaints it has come to our attention, that the SPII Model Lubinus label may be misinterpreted during surgery.

   Waarschuwing | 08-02-2024

7. Waldemar Link GmbH Co.KG, BiMobile Dual Mobility System, Liner

   On the affected labels of the BiMobile Liner there is an incorrect letter “F” referring to the compatible size of the MobileLink ...

   Waarschuwing | 08-02-2024

8. Stryker Joint Replacement, HRIS ACET CUP CUT TIP

   Stryker has discovered that the HRIS Acetabular Cup Cut Tips may puncture their inner and outer packaging or damage the packaging ...

   Waarschuwing | 22-01-2024

9. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

   It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

   Waarschuwing | 04-01-2024

10. Stryker Joint Replacement, RA2023-3471895, Scorpio, Duracon, PCA, Trident

    The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the ...

    Waarschuwing | 19-12-2023