Statement on media coverage regarding ImplantFiles

27.11.2018

Description

An FSCA is not automatically linked to patient injury

Despite strict quality controls and precisely defined manufacturing processes, undesired incidents may occur in the application of medical devices, which can result in FSCAs (Field Safety Corrective Actions). As a matter of principle, our reports are voluntary safety measures that are taken as correc-tive actions to protect the user and the patient. 

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