Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Stryker Trauma GmbH Kiel, FSN-PFA 2365134, Sterile packaging of T2 Locking Screws, Compression Screws, End Caps, Gamma3 End Caps

   The purpose of this notification is to advise you that Stryker Trauma GmbH (Trauma & Extremities Division) is conducting a ...

   Waarschuwing | 30-04-2020

2. Intervascular SAS RC034 - HEMASHIELD GOLD - HEMASHIELD PLATINUM

   The issue was identified through five complaints received between July 2018 and September 2019 reporting intra-operative bleeding ...

   Waarschuwing | 23-03-2020

3. Stryker GmbH 2227937 - Pin To Rod Coupling Hoffmann II Compact 5/3-4mm

   The purpose of this notification is to advise you that Stryker GmbH (Trauma & Extremities Division) is conducting a voluntary ...

   Waarschuwing | 19-10-2019

4. Xtant Medical 3005031160-1 2_31_2018-001-R - Calix Spinal Implant System

   The potential product problem that emerges is an increased probability that product not shipped individually packaged and sterile ...

   Waarschuwing | 15-04-2019

5. Zimmer Biomet ZFA 2018-00611 - Foot and Ankle Instruments

   Zimmer Biomet received a certain number of complaints reporting tip breakages. An investigation identifies that Normed Medizin ...

   Waarschuwing | 27-03-2019

6. Johnson & Johnson thermachoice 111 Catheter Voluntary Recall - Gynecare thermachoice lll catheter

   Ethicon, Inc. ("ETHICON") has initiated a voluntary recall of the GYNECARE THERMACHOICE™ III Thermal Balloon Ablation Silicone ...

   Waarschuwing | 02-12-2015

7. GELITA MEDICAL GmbH, FSN-CR-22-006, GELITA-SPON STANDARD, GELITA-SPON RAPID3, GELITA ENT X-BLOD, GELITA ENT X-DENSE, GELITA ENT X-PAND, GELITA ENT X-PASTE, GELITA-SPON POWDER

   In re-testing ordered by the manufacturer, the endotoxin concentration of the product in some samples has been measured above the ...

   Waarschuwing | 16-08-2022

8. Bien-Air Surgery SA, FSN-CAPA-2020003, Foot Pedals

   This field safety corrective action has been initiated because there is a low possibility that the magnet located insid e the ...

   Waarschuwing | 11-09-2020

9. Teleflex EIF-000392 - Pilling CLEAR ADVANTAGE

   Teleflex voert een terugroepactie uit voor de bovenstaande productcodes en partijen zoals vermeld in Appendix 2. Het is mogelijk ...

   Waarschuwing | 24-01-2020

10. Field Safety Notice: Zimmer Biomet - verscheidene tandheelkundige producten

    Daar bij het versturen van verscheidene tandheelkundige onderdelen naar de klant alleen de standaard gebruiksaanwijzing is ...

    Waarschuwing | 13-08-2017