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-2056-2017

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief