FDA-Device2016-08-31Class II
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Encore Medical, Lp
Hazard
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
Sold states
US Nationwide Distribution
Affected count
866 units
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2606-2016Don't want to check this manually?
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