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# More Recalls with 510(k)s Than PMAs: Study
- URL: https://www.fdaweb.com/more-recalls-with-510-k-s-than-pmas-study/
- Published: 2018-08-14T12:00:00.000Z
- Updated: 2026-09-15T00:25:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142110

A University of Texas Medical study reported in the open access journal *Cureus* finds that medical device recall is not an uncommon event with the majority of products cleared for marketing through FDA’s least strenuous 510(k) process. The researchers looked at all foot and ankle devices from 2007 through 2017 and found 161 products from 33 companies, with 98.1% (158) cleared through the 510(k) process. The most common recall reason was due to the device breaking intraoperatively or postoperatively.

The researchers conclude that “a large proportion of implants used for foot and ankle surgery approved through the 510(k) process were recalled when compared to the proportion of implants approved through the more stringent PMA process. Surgeons should stay abreast of recalls amongst the products that they use frequently…. Streamlining the PMA process or changing the 510(k) process may enable manufacturers to improve upon the safety of their devices.”