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BioWorld - Tuesday, May 13, 2025
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Home » TGA de-lists STAR ankle device due to high rates of device fracture
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TGA de-lists STAR ankle device due to high rates of device fracture

Sep. 13, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
BioWorld MedTech Regulatory Australia U.S. FDA

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