FDA-Device2021-06-09Class II

VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.

Zavation
Hazard

Products distributed as sterile may not have been adequately sterilized

Sold states
US nationwide distribution.
Affected count
35 units
Manufactured in
220 Lakeland Pkwy, Flowood, MS, United States
Products
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1770-2021

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