NuVasive Inc recalls X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

Recalled December 28, 2022 · FDA recall Z-0738-2023 · NuVasive

Hazard

Potential that insert will be unable to disengage from the vertebral body replacement device/implant · FDA Class II

Units

2,031 devices

Sold at

Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spain, and United Kingdom.

Description

Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Product

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

Manufacturer(s)

NuVasive Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →