Investigation and analysis of four countries' recalls of osteosynthesis implants and joint replacement implants from 2011 to 2021.

ABSTRACT:

Background

Medical devices are used in almost all orthopedic surgical subspecialties, and the frequency of adverse events is increasing, which should not be ignored. To provide suggestions on how to avoid implant recalls from the perspective of manufacturers, medical institutions and supervisions, as well as how to respond promptly to adverse events.

Methods

The research extracted recalls of osteosynthesis implants and joint replacement implants from January 1, 2011, to June 30, 2021, in the CNMPA, FDA, HC and ATGA websites and collected the information on device name, recall time, recall class, recall manufacturer, device classification and affected areas. Moreover, the McKinsey 7S model and fishbone diagram were used to analyze recall reasons.

Results

A total of 315

SUBMITTER: Wang Y 

PROVIDER: S-EPMC9547470 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature