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Kyphon Bone Cement Lawsuit

Kyphon Bone Cement Lawsuit

Medtronic Inc. has recalled all lots of Kyphon® bone cement devices because a misalignment issue could result in nerve damage, paralysis, pulmonary embolism, cardiac arrest, or death.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Kyphon induced injury cases in all 50 states. If you or somebody you know has been diagnosed with nerve damage or a serious side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Kyphon Directional Bone Filler Recall

Medtronic Inc. announced a recall for all lots of the Kyphon® and Kyphon® Express Directional Bone Void Filler devices with an Urgent Field Safety Notice to customers on May 17, 2017,

There were two reports of a misalignment issue that could result in bone cement being injected into a patient’s bloodstream, spinal cord, or “a direction unintended by the surgeon,” according to Medtronic.

No injuries have been reported to date, but the problem could result in life-threatening health consequences for a patient:

“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.”

The problem is that a directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. The FDA designated it as a Class II recall on June 3, 2017.

The recall involves approximately 17,650 units with Product #F04C, including all lots of the devices. Medtronic is asking customers to identify the recalled devices and remove them from normal storage locations. Medtronic sales representatives will arrange for a return.

Do I have a Kyphon Lawsuit?

The Schmidt Firm, PLLC is currently accepting Kyphon induced injury cases in all 50 states. If you or somebody you know has been diagnosed with nerve damage or a serious side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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