Knee Replacement Recalls | 合法醫療器材資訊網

ManufacturersandtheFDAhaverecalledhundredsofkneeimplantdevicesandcomponents.KneeimplantrecallsinvolvepopularbrandsfromZimmerand ...

The advocacy group Consumers Union reviewed the U.S. Food and Drug Administration’s medical device database and found that 709 knee replacement recalls were issued between 2003 and 2013. Drugwatch conducted a separate review in 2018 and identified another 76 recalls. Roughly 97% of all recalls during that timeframe involved knee replacements[1] from just three manufacturers: Zimmer Biomet, DePuy and Stryker.

Smith & Nephew recalled more than 42,000 Journey I BCS Knee Systems in 2018 after joint registries in the United Kingdom and Australia — which collect data on joint replacement surgeries to improve patient care — reported the device’s revision surgery rates were 1.5 times that of the average for all knee replacements.

Knee implant manufacturers are responsible for appropriate marketing...