Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. Medtronic Navigation Inc., FA1384, Pin, 9733235/9733236, 100MM/150MM, Sterile, Perc Ref

   Medtronic is zich ervan bewust geworden dat bepaalde partijen percutane pennen (zie Tabel 1) een kruispen bevatten waardoor de ...

   Waarschuwing | 19-12-2023

3. Intuitive Surgical, Inc., ISIFA2022-14-C Expansion, a Vinci Xi and da Vinci X Surgical System

   This Field Safety Notice is to notify you that a population of the da Vinci X and Xi system instrument arms (USMs) have ...

   Waarschuwing | 13-11-2023

4. 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

5. Bort GmbH, 1013xxx-RR, Bort X-Walker

   Due to a material and design issue, the blue connecting bolts which attach the fasteners and D-rings to the gray walker shell may ...

   Waarschuwing | 03-11-2023

6. Biomet Orthopedics LLC, ZFA2023-00161, OSS™ Compress® & Mini Compress® Anchor Plugs

   The impacted anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from ...

   Waarschuwing | 02-11-2023

7. Biomet Spain Orthopaedics, S.L., Polished Finned 1 Piece Tibial Tray 83 mm

   After investigation, it has been concluded that, the external labeling corresponds with a Polished Finned 1 Piece Tibial Tray 83 ...

   Waarschuwing | 31-10-2023

8. 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 | 06-10-2023

9. 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

10. MEDICREA INTERNATIONAL S.A., FSN-FA1335, GRANVIA-C, IMPIX ALIF, IMPIX ALIF S/A, IMPIX C+. IMPIX DLIF, IMPIX MANTA, IMPIX MANTA+, IMPIX S, IMPIX TLIF, PASS LP

    Tijdens een intern onderzoek ontdekte Medtronic de mogelijkheid van een productconformiteitsprobleem in de vorm van een gaatje in ...

    Waarschuwing | 18-07-2023