Stryker Corp, at @US_FDA ' s request, communicated about a higher than expected fracture rate of the polyethylene component in certain STAR Ankle Total Replacement devices distributed before August 2014, and made recommendations for patients and providers. https://www.stryker.com/content/dam/stryker/foot-and-ankle/products/star/resources/STAR%20Non-Foil%20UHMWPE%20Safety%20Communication%20-%2011OCT2019.pdf   …

Stryker Corp, at @US_FDA's request, communicated about a higher than expected fracture rate of the polyethylene component in certain STAR Ankle Total Replacement devices distributed before August 2014, and made recommendations for patients and providers. https://www.stryker.com/content/dam/stryker/foot-and-ankle/products/star/resources/STAR%20Non-Foil%20UHMWPE%20Safety%20Communication%20-%2011OCT2019.pdf …
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news