More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study.
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.