The Fridley, Minn.-based company sent a letter to customers last month detailing the issue with the Kyphon directional 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.”
That means the cement could be injected in “a direction unintended by the surgeon,” Medtronic said in the letter. The problem hasn’t resulted in any reports of injuries, which could include paralysis, nerve injury, pulmonary embolism or cardiac arrest if the cement is injected into the spinal canal, the company said.
The recall affects all lots of the Model F04C filler, according to the letter, which asked that all affected products be returned to the company.
* CORRECTION: This article originally and incorrectly stated that Medtronic is recalling the Kyphon bone cement, not the filler instrument that is being recalled. ↩