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Medtronic recalls Kyphon directional bone void filler

July 8, 2017

Medtronic Ltd. announced the recall of its Kyphon directional bone void filler, product #F04C. The recall includes all lot numbers.

According to an urgent field safety notice from the company’s regulatory affairs manager of the United Kingdom and Ireland, the directional arrow at the proximal end of the Kyphon may not correctly align with the opening on the distal end of the instrument, which may cause the cement to be injected in a direction the surgeon did not intend. Risks correlated with this misalignment include cement extravasation into the spinal canal, which may lead to paralysis or nerve injury with a risk of pulmonary embolism or cardiac arrest. According to the notice, the company has received two reports of misalignment thus far; however, no associated patient injuries have occurred.

FDA News

Zimmer Biomet recalls implantable spinal fusion stimulators

May 31, 2017
Zimmer Biomet announced a recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators, according to a release from the FDA. The devices are used…

Medtronic receives FDA 510(k) clearance for bone cement indicated for treatment of sacral fractures

March 20, 2017
Medtronic announced it has received FDA 510(k) clearance for Kyphon Xpede bone cement for treatment of pathological fractures of the sacral vertebral body, according to…
From OT Europe

Synergy Biomedical receives CE mark for next generation bone graft

March 20, 2017
Synergy Biomedical LLC announced it has received CE mark approval in the European Union for Biosphere Putty, the company’s next generation bone graft. According…
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