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URGENT MEDICAL DEVICE RECALL NOTIFICATION
PRODUCT: Stryker Navigation Thoracic Pedicle Feeler
ATTENTION: OR DIRECTOR, RISK MANAGER, MATERIALS MANAGER
October 16, 2017,
The purpose of this notification
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How to fill out class 2 device recall
How to fill out class 2 device recall
01
Identify the reason for the recall of the class 2 device
02
Obtain the necessary forms and documents from the regulatory authorities
03
Notify all affected customers and distributors of the recall
04
Provide instructions for returning or replacing the devices
05
Keep detailed records of the recall process
Who needs class 2 device recall?
01
Medical device manufacturers who have identified issues with their class 2 devices
02
Healthcare facilities or providers who have received or distributed the affected devices
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What is class 2 device recall?
A Class 2 device recall is a type of recall in which the FDA determines that a device may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Who is required to file class 2 device recall?
Manufacturers, importers, and distributors of medical devices are required to file a Class 2 device recall with the FDA when they identify a problem that could affect the safety or effectiveness of the device.
How to fill out class 2 device recall?
To fill out a Class 2 device recall, one must complete the FDA's Recall Report Form, detailing the device's information, reason for the recall, and steps taken to notify customers and stakeholders.
What is the purpose of class 2 device recall?
The purpose of a Class 2 device recall is to protect public health by removing devices that could pose a temporary risk to health from the market, ensuring safety and effectiveness.
What information must be reported on class 2 device recall?
The information that must be reported includes device identification, the problem with the device, affected lot numbers, quantity recalled, and a description of the recall strategy.
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