Medtronic is recalling all lot numbers of KYPHON Directional Bone Void Filler over a misalignment problem that may cause injected cement to be placed in an unintended direction.
What’s the Problem?
July 10, 2017 – Medtronic Inc. sent an Urgent Field Safety Notice to customers last month detailing the problem with Kyphon bone filler, saying it received 2 reports 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.”
This issue could result in bone cement being injected unintentionally into the spinal canal, which could increase the risk of complications including paralysis, nerve injury, pulmonary embolism or cardiac arrest, according to Medtronic.
The recall affects all lots of the Model F04C filler (Product # F04C), according to the letter, which asked that all affected products be returned to Medtronic. Approximately 17,650 units distributed worldwide.