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BIOPSYBELL S.R.L. recalls EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Recalled May 26, 2021 · FDA recall Z-1636-2021 · BIOPSYBELL S.R.L
Hazard
Products labeled as sterile were distributed, but may not have been sterilized. · FDA Class II
Units
5 units
Sold at
US Nationwide distribution in the states MS and KY.
Description
Products labeled as sterile were distributed, but may not have been sterilized.
Product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Manufacturer(s)
BIOPSYBELL S.R.L.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →