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FIELD ACTION NOTIFICATION IMMEDIATE RESPONSE REQUIRED February 23, 2017, To:Zimmer Singapore PTE Subject:URGENT MEDICAL DEVICE REMOVAL LOT SPECIFICAffected Product: assist Validation Tool Zimmer Biome
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To fill out the field action notification, follow these steps:
02
Access the field action notification form.
03
Provide the necessary information such as the date and time of the action, the location, and the type of action.
04
Include the details of the action, such as the purpose, the participants involved, and any specific instructions.
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Who needs field action notification?
01
Field action notifications are usually required by organizations or departments responsible for managing field operations or conducting on-site actions.
02
This may include field service personnel, field engineers, construction teams, maintenance teams, or any other team involved in fieldwork.
03
Field action notifications help ensure proper coordination, documentation, and compliance during field operations.
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What is field action notification?
Field action notification is a communication from a manufacturer to inform regulatory authorities and customers about actions taken in relation to a product that may pose a health risk or fail to meet regulatory requirements.
Who is required to file field action notification?
Manufacturers of medical devices are required to file field action notification.
How to fill out field action notification?
Field action notification can be filled out online through the appropriate regulatory authority's portal or submission system.
What is the purpose of field action notification?
The purpose of field action notification is to protect public health by notifying regulatory authorities and customers about actions taken to address potential risks associated with a product.
What information must be reported on field action notification?
Field action notification must include details about the product, the reason for the action, the potential health risks, the actions taken, and contact information for further inquiries.
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