MD Recall root cause

#1
Hi

I am working for a surgical instrument manufacturer, and would like to sensibilize my team about Medical Device recall.
Does someone knows about the main root causes of the FDA recall ( design / Labelling/ sub contracting issues/ ….)

I can’t find something on the web

Thanks a lot
 
Elsmar Forum Sponsor
#3
Hi Jim
I am just looking for the main reasons, for instance design issue, manufacturing issue, subcontracting issue, labelling issue ...... just high evel reasons
Thanks for your help
 

chris1price

Trusted Information Resource
#4
If you go into the FDA databases, you can export all the recalls into an excel file, together with the reason for the recall. Unfortunately this won't give too much information and you would have to review them individually. Also, you can only pull 500 records at a time

Medical Device Recalls

However, at a guess, I'd say the most common are manufacturing failing to meet specification or having defects, followed by design and labelling/packaging issues.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#5
These are aggregated categories of the source of the root causes.
The reason for a recall would be the actual experienced problem.
 
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