FDA-Device2021-05-26Class II

EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS

BIOPSYBELL S.R.L.
Hazard

Products labeled as sterile were distributed, but may not have been sterilized.

Sold states
US Nationwide distribution in the states MS and KY.
Affected count
5 units
Manufactured in
Via Aldo Manuzio N. 24, Via A.Manuzio n.24, Mirandola, N/A, Italy
Products
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2021

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