Medtronic has recalled all lots of the KYPHON® and KYPHON® Express Directional Bone Void Filler (Product #F04C) due to a misalignment issue that could cause cement to be injected into a patient’s spinal cord.
Medtronic issued the recall after discovering that the directional arrow at the proximal end of the instrument may not correctly align with the cut-out opening on the distal end of the instrument.
Using the recalled bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
According to the recall notice, the problem is associated with paralysis and other potentially deadly complications:
Possible risks associated with this misalignment include cement extravasation into the spinal canal with a possible result of paralysis or nerve injury with a risk of pulmonary embolism or cardiac arrest.”
Medtronic has received two reports of this type of misalignment. There have been no patient injuries resulting from this issue as of May 2017.
Medtronic is asking customers not to use the recalled products. The products should be located and removed from normal storage locations. Medtronic Sales Representatives will contact customers to facilitate the return of any recalled products in customers’ possession.