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FDA Rules on Medical Device Recalls

| Oct 26, 2010

The U.S. Food and Drug Administration doesn't just advise recalls on food and medicine, but also medical devices. Any medical device found violating FDA law due to defect, health risk or both, could be recalled by the FDA .

When a medical device is recalled, it could mean any of the following:

  • The device in question requires an alteration, adjustment, or repair
  • An inspection of the device is in order
  • Use of the device should be discontinued
  • The patient with the device will require regular medical monitoring

While the FDA rules on medical device recalls, it can't make companies issue the recall. It can only oversee the recall to ensure the manufacturer takes adequate steps to protect the public and to achieve legal compliance and precautions to prevent the occurrence of similar problems in the future

As a North Charleston personal injury attorney , I have seen this relationship cause some problems. In July 2010, DePuy Orthopaedics recalled its ASR hip implants because of reports the device had an early failure rate of 12-13 percent, but the FDA knew about the reports two years before the recall. If you or a loved one have been affected by a medical device because the recall was too late, contact a North Charleston personal injury lawyer .

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