Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Skulle Implants FSN0719 - GLACE Screws 6 mm

   Skulle Implants Corporation is conducting a medical device Field Safety Corrective Action for the GLACE^TM CMF 6 mm screws due to ...

   Waarschuwing | 08-07-2019

2. Zimmer Biomet ZFA2018-00529 - Oxford Unicompartmental Knee Drill Guides

   Zimmer Biomet is conducting a lot specific medical device field action for the Oxford Unicompartmental Knee Drill Guides (Phase ...

   Waarschuwing | 08-05-2019

3. Zimmer Biomet ZFA2019-00046 - T7 Cannulated Driver AO and T7 Driver Solid AO

   Zimmer Biomet is conducting a removal of the T7 Cannulated Driver AO and T7 Driver Solid AO due to the potential of fracture, ...

   Waarschuwing | 10-04-2019

4. Thommen Medical FSCA 19_01 - Adapter for handpiece, guided reusable

   Thommen Medical AG has found parts in a production batch of the above-mentioned medical device whose hardness does not conform to ...

   Waarschuwing | 27-03-2019

5. Synthes GmbH, 1449426, Femoral Neck System Insert for Insertion Handle

   Synthes GmbH heeft ontdekt dat de perspassing van de insert componenten tijdens de fabricage van de hierboven genoemde lotnummers ...

   Waarschuwing | 01-03-2019

6. Field Safety Notice: Implant Direct Sybron Manufacturing LLC, Spectra-System®

   Through our Regulatory Affairs reporting process we have found that the product may be out of Implant Direct specification.

   Waarschuwing | 27-07-2017

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. Smith & Nephew Inc. FSN-R-2021-07 CPCS Distal Centralizer

   This letter is to inform you that Smith & Nephew, Inc. has initiated a Field Action to voluntarily remove a single batch of 10MM ...

   Waarschuwing | 30-08-2021

10. Synthes GmbH, FSN-1882308, RIA 2 (Reamer Irrigator Aspirator)

    Synthes GmbH initieert een vrijwillige veiligheidsmededeling voor alle lotnummers van de RIA 2 (Reamer Irrigator Aspirator 2).

    Waarschuwing | 20-11-2020