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

FDA device recall Z-2056-2017 · posted 2017-04-25 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

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.

Action taken

On 4/13/2017 URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LOD

Quantity affected

4238

Distribution

TX. Japan Mexico

Date initiated

2017-04-13

Date posted

2017-04-25

Date terminated

2019-03-26

Location

Warsaw, IN

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