Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Valoc AG FSN1 FSCA1 Adapter Optiloc for handpiece, length 26mm

   De adapter Optiloc® werkt mogelijk niet goed in het vergrendelingsmechanisme van het handstuk. Dit kan resulteren in een gebrek ...

   Waarschuwing | 07-04-2020

2. Stryker Trauma GmbH Kiel PFA 2219868 - Delta Strike Plate IMN Instruments

   The manufacturer has discovered that the instrument can break at the level of the thread when being exposed to high forces during ...

   Waarschuwing | 25-11-2019

3. Euros FSCA-2019-01 - E. SPINE TANIT - Iliosacral Connector

   Further to a customer complaint, it was found that few units of Sterile lliosacral connector of the batch mentioned above may ...

   Waarschuwing | 25-10-2019

4. Integra LifeSciences, N-HHE-342A, CUSA Clarity Console

   Integra LifeSciences heeft recent via een interne controle opgemerkt dat de gebruikershandleiding bijgewerkt moet worden om de ...

   Waarschuwing | 14-10-2019

5. Ad-Tech Medical 22-08-2019-00001 - Drill Sleeve Guide

   On August 22, 2019, Ad-Tech Medical Instrument Corporation decided to voluntarily recall all drill sleeve guides which are ...

   Waarschuwing | 22-08-2019

6. Stryker Spine - Leesburg RA2018-2093200 MESA 2 Deformity Polyaxial Screw; Size Ø6.5x45 mm

   A single lot of MESA 2 Deformity Polyaxial Screws was packaged with the incorrect Instructions for Use (IFU). Instead of the ...

   Waarschuwing | 05-08-2019

7. IMACTIS SAFNT 19-001 - IMACTIS Single Use Navigation Kit

   One of the components of this kit, the sensor cover under reference PC3688, is being recalled by its manufacturer ECOLAB. A ...

   Waarschuwing | 30-07-2019

8. Zimmer, Inc - ZFA 2019-00062 - Pulsavac Plus Wound Debridement System

   Zimmer Surgical, Inc. is conducting a medical device Field Safety Corrective Action (removal) for lot specific Pulsavac® Plus ...

   Waarschuwing | 08-07-2019

9. MEDICREA INTERNATIONAL - MAT 2019-11 - cervical cages (IMPIX MANTA, IMPIX MANTA+, IMPIX C and C-Curve) and lumbar cages (IMPIX-L)

   Titanium radiopaque markers were placed in cages instead of Tantalum markers. The objective of these markers is to verify the ...

   Waarschuwing | 11-06-2019

10. Mathys AG Bettlach, FSCA 19/03, twinSys impactor with offset

    Uit gegevens van de algemene controle na het vermarkten blijkt dat er tijdens het inslaan van de heupsteel meermaals een breuk is ...

    Waarschuwing | 30-04-2019