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March 31, 2020, To:HospitalSubject:URGENT MEDICAL DEVICE FIELD SAFETY NOTICE REMOVALReference:ZFA202000012Affected Product: Comprehensive Reverse Shoulder Geosphere Mini Baseplate with Taper Adapter
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How to fill out class 1 device recall
How to fill out class 1 device recall
01
Identify the reason for the recall
02
Notify the appropriate regulatory bodies
03
Prepare a recall strategy and communication plan
04
Determine the scope of the recall
05
Issue a recall notification to affected customers
06
Coordinate with distributors and retailers to facilitate the recall process
07
Monitor and track the recall progress
08
Close out the recall once all affected devices have been accounted for
Who needs class 1 device recall?
01
Medical device manufacturers
02
Distributors and retailers of medical devices
03
Regulatory bodies overseeing medical device safety
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What is class 1 device recall?
Class 1 device recall is the most serious type of recall issued by the FDA for devices that have a high risk of causing serious injury or death.
Who is required to file class 1 device recall?
Manufacturers, distributors, and importers of the device are required to file a class 1 device recall.
How to fill out class 1 device recall?
Class 1 device recall can be filled out by submitting a written report to the FDA with detailed information about the device and the reason for the recall.
What is the purpose of class 1 device recall?
The purpose of class 1 device recall is to remove the defective device from the market to prevent further harm to the public.
What information must be reported on class 1 device recall?
Class 1 device recall must include information on the reason for the recall, the number of affected devices, the potential risks, and the actions being taken to address the issue.
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