The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0738-2023·Announced 2022-12-28

Spinal implant insert may fail to disengage from vertebral body device

NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves a spinal implant with potential mechanical failure that could require revision surgery. No adverse events have been reported, but the risk of harm from device malfunction justifies a High severity rating.

Plain-English summary

NuVasive Inc. is recalling 2,031 units of the X-CORE 2 Ti Core, Static implant, which is part of the NuVasive X-Core Expandable Vertebral Body Replacement (VBR) system used in spinal fusion surgeries.

The recall addresses a potential mechanical failure: the implant insert may become unable to disengage from the vertebral body replacement device. This could complicate revision surgeries or require additional intervention if the components cannot be separated as intended.

The affected devices were distributed worldwide to the United States, Australia, Belgium, Brazil, Colombia, Germany, Italy, Spain, and the United Kingdom. The recall includes multiple lot numbers across five part numbers (7160012, 7160014, 7180016, 7180018, 7220016, and 7220018).

Healthcare providers and patients should contact NuVasive Inc. or the FDA if they have questions about affected implants. Patients with implanted devices should consult their healthcare provider for guidance.

The recalled product

Product
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Manufacturer
NuVasive Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
2,031

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Numbers / UDI-DI Code: 7160012 /887517424204

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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