Q: What is a medical device recall?
A: The U.S. Food & Drug Administration regulates all medical devices. This can include anything from a simple tongue depressor to a surgical implant. A medical device recall can occur when a device is found to violate FDA rules because it is either defective, a health risk, or for other reasons.
Q: What does it mean if a recall is issued for a medical device I am using?
A: A recall does not simply mean to stop using the device. Just as a recall notice for a part in your car would prompt you to bring the vehicle to the dealership for a check-up, adjustment, or a replacement part, a medical device recall should prompt you to follow up with your medical care provider immediately to determine what, if anything, you should do.
Q: Who decides what devices should be recalled?
A: Often the medical device manufacturer or distributor will voluntarily issue a medical device recall or pass the necessary information along to the FDA. While not always necessary, the FDA can require a company to issue a recall in the case of a device known to cause severe health issues.
Q: What procedures are followed before a recall is issued?
A: The FDA reviews the plan put together by the medical device manufacturer or distributor to rectify the issue and any and all health hazards posed by the malfunction. The FDA seeks to determine if this malfunction violates FDA rules. Lastly, the FDA assigns a classification. Recall classifications are as follows according to FDA.gov:
Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death.
Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
Class III: A situation where a product is not likely to cause any health problems or injury.
Q: What medical devices recalls have been issued recently?
A: Recent medical device recalls include CPAP and BiPAP ventilator machines, Exactech Knee & Ankle replacement implant systems, metal on metal hip implant models, and hernia mesh.
If you or a loved one have been injured by a medical device, call DeGaris Law today for a FREE CONSULTATION.