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[Notification date]URGENT FIELD SAFETY NOTICE: Medical
Device Field Safety Corrective Action / Recall
Reference:
R201725
Concerned Devices: 12 14 Coca Femoral HeadProduct No.
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Start by gathering all necessary information related to the safety concern or incident.
02
Clearly identify the issue and provide detailed description in the safety notice.
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Clearly state any actions that need to be taken to ensure safety.
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Who needs field safety noticewho?
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Field technicians, maintenance workers, and any other personnel who encounter safety concerns or incidents in the field.
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What is field safety notice?
Field safety notice is a notification that must be submitted to regulatory authorities by manufacturers, authorized representatives, or distributors when a product poses a risk to the health or safety of consumers.
Who is required to file field safety notice?
Manufacturers, authorized representatives, or distributors are required to file field safety notice.
How to fill out field safety notice?
Fill out the field safety notice form provided by the regulatory authorities with all the required information about the product and the safety issue.
What is the purpose of field safety notice?
The purpose of field safety notice is to inform regulatory authorities about a product that poses a risk to the health or safety of consumers and to take necessary actions to address the issue.
What information must be reported on field safety notice?
The information reported on field safety notice must include details about the product, the safety issue, the actions taken to address the issue, and contact information for the responsible party.
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