Issue: May 2017
May 08, 2017
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Synthes GmbH initiates product removal of DePuy Synthes Radial Head Prosthesis System

Issue: May 2017
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Synthes GmbH has initiated a product removal of the DePuy Synthes Radial Head Prosthesis System intended for primary and revision joint replacement of the radial head.

According to an urgent notice released by the company, the radial stem has the possibility of loosening postoperatively at the stem bone interface, which is believed to be caused by multiple factors that have not been fully characterized. The release noted, except for the stem, “the DePuy Synthes Radial Head Prosthesis System will be available upon request for revision surgeries in which only the head would be replaced using the evaluation or loaner set programs only.”

Reference:

www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202017/16-1-2017/RadialHeadProsthesisSystem.pdf