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

Recall date

November 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0738-2023

FDA classification

Class II

Brand / firm

NuVasive Inc

Sold / distributed

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, Spa…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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