The recalls were initiated because of issues affecting the inner blister and outside sterile blisters of the implant packaging, according to the FDA. Notifications dated Feb. 6 were sent out to facilities asking to return recalled devices to Stryker’s Mahwah, N.J., location.
The Triathlon total knee system has been implanted in more than 3 million patients worldwide and is compatible with the Mako robot, according to Stryker’s website.
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