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March 5, 2018To:Risk ManagersSubject:URGENT MEDICAL DEVICE RECALLAffected Product: Comprehensive Segmental Revision System (SRS) See Attachment 1 Affected Product List (LOT SPECIFIC) Zimmer Biome
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What is subject urgent medical device?
Subject urgent medical device refers to a medical device that poses an immediate threat to health, public safety, or the environment.
Who is required to file subject urgent medical device?
Manufacturers, distributors, and importers of medical devices are required to file subject urgent medical device reports.
How to fill out subject urgent medical device?
Subject urgent medical device reports can be filled out online through the designated regulatory agency's website.
What is the purpose of subject urgent medical device?
The purpose of subject urgent medical device reports is to alert regulatory agencies and the public about potential risks associated with the medical device.
What information must be reported on subject urgent medical device?
Subject urgent medical device reports must include details such as the nature of the defect, potential hazards, and actions taken to address the issue.
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