Nuvasive Recall

If You Suffered A Harmful Side Effect After Receiving A NuVasive Precice Device, You May Be Entitled to Compensation

Precice devices are implants intended for people age 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism.

The FDA Has Received Reports Describing Pain and Changes in Surrounding Bone and Soft Tissue

These adverse events may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing. At this time, the FDA is uncertain if the root cause of these adverse events is due to the stainless-steel material or related to design features and materials common to all Precice devices.

FDA recommends monitoring patients with the following NuVasive devices:

Stainless Steel (Biodur 108)-Based Precice Devices:

  • Precice Bone Transport
  • Precice Plate
  • Precice Stryde

Titanium-Based Precice Devices:

  • Precice Freedom
  • Precice Intra-medullary Limb Lengthening (IMLL) Device
  • Precice Short
  • Precice Unyte

On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices.

Bibliography
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