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This document is a field safety notice issued by Zimmer Biomet regarding a medical device correction for the Persona Partial Knee Impactor Pad, detailing updates to the surgical technique and responsibilities

How to fill out urgent field safety notice

How to fill out urgent field safety notice

1. Identify the medical device or product that is subject to the field safety notice.
2. Gather all relevant details such as the model, serial numbers, and any affected batches.
3. Clearly outline the issue that led to the safety notice, including potential risks and consequences for users.
4. Specify the actions that need to be taken by the recipients of the notice, such as returning the product, performing corrective measures, or contacting customer support.
5. Provide a deadline for compliance or response from the recipients.
6. Include contact information for further questions or assistance.
7. Review and ensure the notice is concise, clear, and free of jargon for better understanding.

Who needs urgent field safety notice?

1. Healthcare providers and professionals who use the affected medical device.
2. Patients who may be impacted by the safety issue.
3. Distributors and suppliers responsible for the distribution of the device.
4. Regulatory bodies that require documentation of safety alerts.

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What is urgent field safety notice?

An urgent field safety notice is a communication issued by a manufacturer or regulatory authority to inform relevant stakeholders about a potential safety issue related to a medical device or product that may pose a risk to patients or users.

Who is required to file urgent field safety notice?

Manufacturers and authorized representatives or distributors of medical devices are required to file an urgent field safety notice when a potential safety issue is identified that requires immediate action.

How to fill out urgent field safety notice?

To fill out an urgent field safety notice, include details such as the device identification, nature of the risk, recommended actions for stakeholders, contact information for further inquiries, and any other relevant information to ensure clarity and urgency.

What is the purpose of urgent field safety notice?

The purpose of an urgent field safety notice is to promptly alert users, healthcare professionals, and other stakeholders about safety concerns, guiding them on necessary actions to mitigate risks associated with the use of a medical device.

What information must be reported on urgent field safety notice?

The information that must be reported includes the device name and serial number, description of the issue, potential risks, recommended actions to be taken, and a timeline for compliance, along with contact details for further assistance.