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Zavation recalls VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Recalled June 9, 2021 · FDA recall Z-1770-2021 · Zavation
Hazard
Products distributed as sterile may not have been adequately sterilized · FDA Class II
Units
35 units
Sold at
US nationwide distribution.
Description
Products distributed as sterile may not have been adequately sterilized
Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Manufacturer(s)
Zavation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →