Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. Teleflex Medical, EIF-000368, Auto Endo5 ML

   Teleflex roept bepaalde partijen chirurgische automatische cliptangen terug vanwege een toename van klachten met betrekking tot ...

   Waarschuwing | 14-10-2019

3. Ethicon Endo-Surgery LLC FMJR 19-058 ECHELON FLEX™ Powered Plus ENDOPATH® 60mm Stapler – 340mm shaft

   Ethicon has initiated a voluntary recall of specific product lots and kits of ECHELON FLEX ENDOPATH 60mm Staplers, were ...

   Waarschuwing | 08-10-2019

4. Convatec Limited 2019-006MA Convex Two-Piece Skin Barriers i.e. Natura

   ConvaTec has voluntarily initiated a Field Safety Corrective Action in the form of a Customer Notification for specific product ...

   Waarschuwing | 20-09-2019

5. Integra LifeSciences R-HHE-161 IDRT - Single Layer and IDRT TS

   Tijdens het verpakkingsproces van IDRT TS en IDRT SINGLE LAYER werd vastgesteld dat er bij een gebruiksaanwijzing voor een ...

   Waarschuwing | 12-09-2019

6. B.Braun Surgical, 400435480, MONOPLUS VIOLET 0(3,5) 150cm HR48 LOOP (M)DDP

   From a complaint received from the market, the company detected that some units of the above mentioned reference batch could have ...

   Waarschuwing | 04-09-2019

7. adeor medical AG, MI001, MSI biopsy instruments

   According to current knowledge, incorrect application of the classification regulations has led to the incorrect classification ...

   Waarschuwing | 28-08-2019

8. 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

9. Biomet, ZFA 2019-00185, Calcar Planar Shaft-BIOMET

   The potential issue associated with the instrument is that the end of the shaft could fail to effectively mate with the broach.

   Waarschuwing | 19-08-2019

10. 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