Recall archive / FDA device enforcement
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. — FDA record Z-0738-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
- Reason
- Potential that insert will be unable to disengage from the vertebral body replacement device/implant
- Classification
- Class II
- Recalling firm
- NuVasive Inc
- Quantity
- 2,031 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0738-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Numbers / UDI-DI Code: 7160012 /887517424204, Lot Numbers: EM3755 EM3755 EM3755 EM3761 EM5349 EM5349 EM5349 EM6061 NN1674 NN2646 NN1674 NN2646 NN3352 PD0066 NN3352 PD0515 PD0066 PD0515 7160014 / 887517424211, Lot Numbers: EM3756 EM3756 EM3756 EM3756 EM3762 EM5351 EM6064 EM6062 EM6063 NN1902 NN3350 NN1902 NN3350 PD0392 PD0805 PD0805 PD0392 7180016 / 887517426277, Lot Numbers: EM3763 EM3757 EM3757 EM3757 EM5353 EM5352 EM6068 EM6067 EM6066 EM6065 DR6677 DR6677 DR6901 DR6958 DR7357 DR7357 DR8110 DR8465 DR8897 DR9443 DR7357 DR9592 DR9592 DR9443 DR9592 DR9592 NN1445 NN1445 NN1446 NN1451 NN1445 NN1473 NN1473 NN3294 NN3294 PD0146 PD0146 PD0706 7180018 / 887517426284, Lot Numbers: EM3758 EM3764 EM5354 EM5354 EM6070 EM6069 DR6624 DR6658 DR6957 DR6658 DR7376 DR8930 NN0628 NN0817 NN1360 DR7376 DR7376 NN1891 NN1891 NN1891 NN2971 NN2971 NN3368 NN3368 PD0794 7220016 / 887517434210, Lot Numbers: EM3765 EM3759 EM6072 EM6072 7220018 / 887517434227 Lot Numbers: EM3760 EM3766 EM3760 EM3760 EM6073 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Nov 10, 2022
- Center classification date
- Dec 20, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.