That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows a company to fast-track approval of a device by claiming it “substantially equivalent” to a device that has already been approved and marketed.
The study, which focused on the manufacturer’s reasoning for initiating each recall, found that products breaking during or after implantation (39 products) and sterility concerns (37 products) triggered the highest number of recalls. The other most-cited reasons for recall were labeling (30 products), device design (27 products) and manufacturing defect (22 products). Software design, packaging issue and employee error accounted for the rest.
“Issues with products breaking intraoperatively or postoperatively may have been determined previously if the products had undergone the more demanding PMA process for approval,” the authors wrote. “Sterility issues are often related to packaging which may not have been determined through a different testing protocol.”
A total of 161 products from 33 companies were identified with 158 (98.1%) approved through the 510(k) process. The average length of the recall was 487.5 days.
The largest number of recalled products were Synthes Products cortical and cancellous of various sizes screws (West Chester, Pa.) 19.5 million recalled due to labeling issues. The smallest number of recalled products in commerce were two sizes of DePuy Mitek (Raynham, Mass.) SpiraLok anchors that were recalled secondary to concerns for hardware failure. None had been distributed.
The study, published in the Cureus Journal of Medical Science, is the latest public shaming of FDA over its 510(k) system. The recently released Netflix film, ‘The Bleeding Edge,’ dissects the 510(k) approval process, pointing out that predicate devices that have been recalled still count toward approvals.
“Streamlining the PMA process or changing the 510(k) process may enable manufacturers to improve upon the safety of their devices,” the authors wrote.
The FDA is evaluating the study, according to an agency spokeswoman.
“We continue taking steps to streamline and modernize how we implement post-market actions to address device safety issues to make our response to risks more timely and effective,” the spokeswoman wrote in an email.