Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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