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.