Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Recall date
April 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2056-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
TX. Japan Mexico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

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