RegulatorySpine
Medtronic pulls Infuse bone graft from Australia
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June 30, 2020 / Alan Condon
Medtronic has withdrawn its Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion device from the Australian market as of March 23, according to a statement provided to Becker’s Spine Review.
The decision came after a February News Corp investigation, which reported that spine surgeons were using the product “off label,” according to The Daily Telegraph. A whistleblower revealed that the device was widely being used in unapproved ways without the cage designed to contain it.
Pulled from the Therapeutic Goods Administration — Australia’s medical regulator — the product can now only be supplied through a special access program.