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dsk35 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
Recalls usually occur due to the product no longer adhering to the FDA laws. For instances where certain devices are recalled after 5-8 years, I would say it is usually because of long term adverse effects that are not detectable during the preliminary stages of development or even soon after the device is FDA approved. Certain side-effects are only detected after longer periods of time.