FDA-Device2017-05-17Class II
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Zimmer Biomet, Inc.
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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