# FDA recall Z-0738-2023

> **NuVasive Inc** · Class II · device recall initiated 2022-11-10.

## Product

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

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0738-2023
- **Recalling firm:** NuVasive Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-10
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0738-2023

## Citation

> AI Analytics. FDA recall Z-0738-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0738-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*