Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Waldemar Link GmbH Co.KG, BiMobile Dual Mobility System, Liner

   On the affected labels of the BiMobile Liner there is an incorrect letter “F” referring to the compatible size of the MobileLink ...

   Waarschuwing | 08-02-2024

2. DePuy Orthopaedics FA 2113289 - MODULAR CATHCART UNIPOLAR HEAD

   Tijdens een interne beoordeling werd vastgesteld dat de Cathcart-kop een offset van +5 mm heeft, wat niet was gespecificeerd in ...

   Waarschuwing | 15-06-2022

3. Stryker RA2022-2911584 - Biolox® Delta Ceramic V40™ Femoral Head - update 16-3-2022

   Stryker initiated an urgent, voluntary, lot-specific recall for the Biolox® delta Ceramic V40™ Femoral Head referenced above in ...

   Waarschuwing | 16-03-2022

4. Stryker Joint Replacement, FSN-RA2021-2744351, Restoris® MCK Femoral Trial

   Stryker has discovered that there is a potential that the threads on the Femoral Trial Slaphammer may not engage with the threads ...

   Waarschuwing | 12-07-2021

5. TORNIER SAS, FSN-FA-WMG-2020-011, Aequalis™ Pyrocarbon Humeral Head

   The purpose of this field safety notice is to inform surgeons about the potential patient exposure to the graphite substrate of ...

   Waarschuwing | 18-06-2021

6. Zimmer Biomet ZFA 2020-00026 - StageOne (Select) Bone Cement Spacer Molds

   As a precautionary measure Zimmer Orthopedics is conducting a medical device Field Safety Corrective Action (removal) for ...

   Waarschuwing | 10-03-2020

7. Field Safety Notice: Zimmer Biomet, Vanguard Open Box Femoral Components

   Zimmer Biomet is conducting a lot specific medical device field safety notice for Vanguard Open Box Posterior Stabilized Femoral ...

   Waarschuwing | 30-08-2017

8. Field Safety Notice: Zimmer Biomet - Versys Beaded Hip Stem and Segmental Knee products

   Zimmer Biomet is conducting a medical device field safety notice related to packaging for selected lots of Versys Beaded Hip Stem ...

   Waarschuwing | 09-08-2017

9. Field Safety Notice: Zimmer Biomet, Comprehensive Nano Humeral Components

   Due to the Comprehensive Nano Humeral Component exceeding the EPR when used in the reverse configuration, Zimmer Biomet is ...

   Waarschuwing | 09-06-2017

10. Field Safety Notice: Biomet UK Ltd, Cementless Oxford Partial Knee Unicompartmental Knee Replacement System

    Our records show that partial knee arthroplasty surgeries involving the above listed components are, or have been carried out at ...

    Waarschuwing | 14-03-2017