Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
105 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Zimmer Switzerland Manufacturing GmbH, Biolox Delta Ceramic Femoral Heads
Zimmer GmbH is conducting a medical device Field Safety Corrective Action (removal) for one batch of the Biolox® delta Ceramic ...
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Zimmer Inc., ZFA-2024-00121, CPT®
Zimmer, Inc. is voluntarily initiating a medical device Field Safety Corrective Action (correction) for the CPT Hip System ...
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Stryker Joint Replacement, RA2024-3656765, UNIPOLAR/UNITRAX
Stryker has discovered that the size on the package label of the UNITRAX® Endoprosthesis Head Component potentially may not match ...
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Stryker Joint Replacement, RA2024-3598242, Mako Total Knee
Stryker has discovered specific to the applications listed in Table 1 an increase in the Software Error #3 (SE3) error code when ...
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Waldemar Link GmbH & Co.KG, R-2024-05, Endo-Model-M & Endo-Model SL (Tibial components)
There is a risk that the blind screws of the modular tibial component cannot be loosened intraoperatively. This is necessary if ...
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implantcast GmbH, FSCA_24001, IFU . OPT. MUTARS RS stems and extension pieces
As part of the certification of the MUTARS RS revision system in accordance with the new European regulation MDR (EU) 2017/745, ...
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Blue Belt Technologies, Inc, C-2024-03, Real Intelligence Cori
Klanten ervaren mogelijk wisselend zicht op de REAL INTELLIGENCE-trackerarrays.
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Medtronic Navigation Inc., FA1414, StealthStation® S8 Application - Software App 9735762 Stealth S8 Application
De StealthStation S8-app wordt gebruikt ter begeleiding van chirurgen bij chirurgisch genavigeerde procedures. Een ...
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implantcast GmbH, FSCA 24001,IFU . OPT MUTARS RS stems and extension pieces
You are receiving this safety information because you have been supplied with one of the above sterns and/or one of the above ...
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Stryker Joint Replacement, RA2024-3589151, EXETER 2.5 I M PLUG
Stryker has discovered the potential that the size on the package label of the EXETER 2.5 I M PLUG may not match the device ...