When a company learns that there is a problem with one of its medical devices, it has a responsibility to alert consumers.
The company will propose a correction or removal depending upon the situation. When the manufacturer does so, the FDA refers to this action as a “recall.” Medical devices are recalled when they are a risk to one’s health, are defective, or both.
However, just because a medical device is recalled does not mean that you must stop using it or return it. Sometimes a recall just requires the device to be checked, adjusted, and/or fixed.
Implanted medical devices do not necessarily require removal.
Patients and their doctors must weigh the risks versus the benefits.
Recalling Medical Devices
In some cases, a company (manufacturer, distributor, or another responsible party) voluntarily recalls a medical device. When a company learns that its product violates FDA regulations, it initiates a recall (through correction or removal) and then notifies the FDA. The FDA is also allowed to demand the recall of a medical device.
The FDA will review the company’s proposed strategy, assess the health hazard, and determine whether the issue violates FDA law or requirements. If it does so, it will assign the recall a classification (I, II, or III) -I being the most serious – in order to indicate the relative degree of risk.
The FDA will post about it in the Medical Device Recall Database as well as in the weekly Enforcement Report in order to notify the public. Once the violation has been remedied and the health hazard has been fixed, the FDA can then terminate the recall.
Each year hundreds of thousands of patients undergo hip replacement surgery. Many of these devices have been recalled due to unsafe product defects and side effects, including releasing metallic ions into the patient’s bloodstream and causing Metallosis. Other problems include loosening of the implant, a squeaky hip, joint dislocation, and severe pain.
Graves McLain Can Help.
If a Metal on Metal Hip Implant has injured you or a loved one, we may be able to help.
An experienced attorney will review the details of your case and determine the best course of action. Call us today at 918-359-6600. An experienced attorney will review your situation at no cost to you. Trust our team. We’re here to help.
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