FDA-Device2017-05-17Class II
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Hazard
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
Sold states
TX. Japan Mexico
Affected count
4238
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2056-2017Don't want to check this manually?
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