Stryker—Triathlon Prim CEM FXD BPLT 7 Prostheses: May Be Oversized; Taper May Prevent Insert from Locking on the Baseplate
September 8, 2021 | Strategic Insights for Health System
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Problem:FDA's Center for Devices and Radiological Health (CDRH) states that the internal profile of the above prostheses may be oversized, and there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate. The failure of the insert to fully seat may not be evident on an x-ray unless the insert has dislodged. FDA's CDRH also states that the manufacturer initiated a recall...