FDA Warns of Injury Risks Posed by PEEK Ardis Interbody Spacer

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About a week ago, the PEEK Ardis Inserter was recalled by Zimmer Spine because of a risk inherent in 315 units.  Now, the PEEK Ardis Interbody Spacer, which the Inserter is meant to implant during spinal surgical procedures, is also reportedly experiencing an issue that must be understood by doctors.  Should the medical professional apply heightened amounts of lateral force to the Inserter, the Spacer can break, delaying surgery and potentially causing the patient to lose blood, to suffer nerve damage, to leak cerebrospinal fluid, or to experience a dural tear.  Serious health threats could thus arise, and a fatality also becomes a possibility.  Because the recalled unit and the Spacer work in conjunction with one another, doctors should not use the Spacer until a new inserter is approved and released.

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