Medtronic is recalling all lot numbers of KYPHON® Directional Bone Void Filler (Product # F04C) due to a misalignment issue that may cause injected cement to be placed in an unintended direction.
The recall is ranked as Class II, with ~17,650 units distributed worldwide.
Possible risks include cement extravasation into the spinal canal, with potential for paralysis or nerve injury with risk of pulmonary embolism or cardiac arrest. The company has received two reports of misalignment, and no associated patient injuries are reported to have resulted from this issue.
Sources: MHRA Field Safety Notice, MHRA.gov; Recall Notice, FDA.gov