Recall Z-0738-2023— NuVasive Inc

Name: FDA recall Z-0738-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Class II · Ongoing

Class II FDA medical device recall by NuVasive Inc, initiated 2022-11-10. It names one FDA 510(k) clearance: K090176. 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.

Recalling firm: NuVasive Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-10
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K090176 — NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEMNuvasive, Inc.·cleared 2009-04-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.