Fast-track approved orthopedic devices are facing more recalls | Bart Durham Injury Law

Fast-track approved orthopedic devices are facing more recalls

A study published in the medical journal Cureus shows that an increasing number of orthopedic devices created for the ankle or foot are being fast-tracked for approval by the Food and Drug Administration (FDA). The researchers also found that those that those quickly introduced to the market via the 501(k) pre-market notification process as opposed to the pre-market approval (PMA) process were most apt to be recalled.

Researchers at both San Diego's Navy Medical Center and Galveston's University of Texas Medical Center analyzed the recall records for these recalled orthopedic devices up during the 10-year period leading up to 2017. During that time frame, 161 devices ended up being recalled. The approval process for all but three of them was fast-tracked.

The researchers also found that the recalls spanned a number of different manufacturers. One manufacturer, Synthes, had the most recalls of any of the companies. They'd improperly labeled at least 20 million screws that had been released on the market.

They also found that most of the recalled devices were used to perform either fracture management or joint replacement procedures. Each of these industries generates in excess of $4 million every year.

Of the different recalled devices, 39 broke while being used. Another 37 were not sterile and 30 were labeled incorrectly. Another 27 were poorly designed and 22 were defectively manufactured. Software design deficits, packaging problems and human error were to blame for the remaining recalls.

As with any negligence case, it's the victim's burden to prove that a manufacturer or designer was liable for the injuries they receive. If someone is successful in doing this, they may be able to recover compensation for any injuries they receive including pain and suffering, lost wages and medical expenses. Proving liability is best handled by an experienced Nashville attorney.

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