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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

465 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Zimmer Surgical, Inc., ZFA2023-00208, Zimmer® Dermatome Blades

    There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The ...

    Waarschuwing | 22-09-2023

  2. Thommen Medical AG, 23/01, SPI®ELEMENT impl. RC INICELL®

    Thommen Medical AG is carrying out a recall of a batch of article 4.23.142 "SPI ELEMENT RC INICELL, implant incl. healing cap PF ...

    Waarschuwing | 07-09-2023

  3. Biocomposites Ltd., CC00916, GeneX DS 2.5cc and GeneX DS 5cc

    The Indications should state that ‘genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the ...

    Waarschuwing | 29-08-2023

  4. PEROUSE MEDICAL, CAPA23-051, POLYFILM

    A sealing problem on the packaging of the POLYFILM® has occurred. If the packaging of POLYFILM® has a defective sealing, it can ...

    Waarschuwing | 21-08-2023

  5. Arthrex INC, R537_NL, Knee Scorpion™

    Associated outer labels and label content document for indicated batches display a sterility statement indicating “sterile” via ...

    Waarschuwing | 17-08-2023

  6. Ethicon LLC, 2283226 (2) - PDS Clear Suture Breakage Complaints, PDS II Suture

    lnternal testing on returned product from this lot confirmed that some POS™ Il (polydioxanone) Sutures from this lot did not meet ...

    Waarschuwing | 15-08-2023

  7. St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve, Trifecta Valve w. Glide Technology

    Op 27 februari 2023 heeft Abbott al laten weten dat de mogelijkheid van Structural Valve Deterioration (Structurele ...

    Waarschuwing | 14-08-2023

  8. MAQUET Cardiovascular, LLC, 2242352-06/20/2023-003-R, ACCESSRAIL Platform and Acrobat Systems

    Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade ...

    Waarschuwing | 03-08-2023

  9. Equimedical BV, 2-2023, Equitamp and Equicel and equispon

    In March 2023 the Health and Youth Care Inspectorate (NL) received a compliance and enforcement request (CEF) fom Agentia ...

    Waarschuwing | 31-07-2023

  10. Cook Vandergrift Inc., 2023FA0008, Lead Clippers

    Cook Medical Vandergrift heeft vastgesteld dat de V-vormige verzegeling van de draadknipperverpakking volledig verbroken kan ...

    Waarschuwing | 26-07-2023

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