The Recall Desk
HighFDA (Devices)·Z-1770-2021·Announced 2021-06-09

Orthopedic Spinal Balloon Kit Recalled for Inadequate Sterilization Risk

Zavation's VERTEBREX single balloon kit for spinal procedures is being recalled because distributed units may not have been adequately sterilized, creating a potential infection risk.

What this means for you

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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—inadequate sterilization of a device used in invasive spinal procedures—represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for a High severity score.

Plain-English summary

The VERTEBREX Single Balloon Kit (model VBRX-20-SBK-10), manufactured by Zavation, is used in orthopedic and spinal procedures. The FDA has issued a Class II recall of 35 units distributed nationwide because these products may not have been adequately sterilized.

Inadequate sterilization of medical devices used in invasive procedures creates a risk of infection. The recall affects units with lot numbers 11553ZV, 12276ZV, and 9965ZV.

Patients who have received this device or healthcare providers with unreleased inventory should contact their healthcare provider or Zavation for guidance on monitoring, replacement, or other next steps.

The recalled product

Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
  • inadequate-sterilization
  • infection-risk

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 (3)

  • Lot Numbers: 11553ZV
  • 12276ZV
  • 9965ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category