USA – FDA issues safety warning for ankle replacement device

The FDA today issued a warning regarding the STAR ankle previously made by Stryker (NYSE:SYK) — and the potential for a fracture of the plastic component.

According to an FDA news release, there is a higher-than-expected risk of the polyethylene (plastic) component of the device breaking as early as three to four years after implantation of the STAR (Scandinavian Total Ankle Replacement), which can lead to surgery to repair or replace it.

Stryker divested the STAR ankle to DJO Global in November 2020 as part of its move to acquire Wright Medical