Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BIOTECK SPA, FSCA REF: 230307, BIO-GEN/GRANULES

   The falsified devices bear the name BIO-GEN® and the indication of Bioteck SpA as the manufacturer but have packaging ...

   Waarschuwing | 29-03-2023

2. Sofamor Danek USA, Inc, FSN-FA1305, Grafton Putty, Grafton Crunch, Grafton Flex, Grafton Orthoblend, Grafton Matrix, Grafton Matrix Strips, Grafton Plus Paste, Grafton DBF, Grafton DBF Inject, Grafton Gel, Accelerate Grafton DB, XPANSE Bone Insert

   Het doel van deze brief is u te informeren dat Medtronic specifieke serienummers van Grafton™ DBM terugroept omdat de verpakking ...

   Waarschuwing | 16-02-2023

3. Biomet Microfixation LLC, FSN-ZFA 2021-00204, LACTOSORB TRAUMA PLATING SYSTEM

   As a precautionary measure, Biomet Microfixation LLC is conducting a lot specific medical device Field Safety Corrective Action ...

   Waarschuwing | 30-12-2021

4. Coltene/Whaledent Inc, FSN-2020-01, HYGENIC Dental Dam Forceps

   The purpose of this letter is to advise you that Coltene/Whaledent Inc has identified multiple batches of the HYGENIC Dental Dam ...

   Waarschuwing | 08-06-2020

5. Biomet, ZFA 2019-00009, LactoSorb RapidFlap

   Zimmer Biomet CMF and Thoracic, LLC (“Zimmer Biomet”) is conducting a medical device removal for certain lot numbers of the ...

   Waarschuwing | 11-03-2019

6. Align Technology, CMD-67847, Invisalign System

   As a result of the software release on June 1, 2019, in some instances, customers were able to modify and re-approve a number of ...

   Waarschuwing | 30-10-2019

7. Medtronic Inc., FSN-FA980, StimLoc™ Burr Hole Cover

   Dringende veiligheidskennisgeving StimLoc™-boorgatdopje. Onderdeelnummers 3387S-40, 3389S-40, 3391S-40, 3550S-01, 924256, ...

   Waarschuwing | 25-06-2021

8. Implant Direct HHE-6050-52-60Rev01 - Replant 5.0mmD Abutment Assy 15 deg Angled

   Through our internal Regulatory Affairs evaluation (Health Hazard Evaluation) process, we have found a possible issue with the ...

   Waarschuwing | 31-08-2016

9. exocad GmbH, CAPA #278955, exoplan

   Tijdens een update van gegevens die gebruikt worden in een bibliotheek die wordt meegeleverd met exoplan of beschikbaar is in het ...

   Waarschuwing | 09-11-2023

10. KulzerGmbH, FSN-GNM#300066826; #300066835, PalaXtreme

    Met deze brief wil KulzerGmbH u informeren over gewijzigde maatregelen op het gebied van arbeidsveiligheid en de nieuwe ...

    Waarschuwing | 06-05-2021