FDA-Device2021-05-26Class II
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
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
500 units
Manufactured in
Via Aldo Manuzio N. 24, Via A.Manuzio n.24, Mirandola, N/A, Italy
Products
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2021Don't want to check this manually?
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