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Terminated

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

FDA Recall Z-2056-2017 · Posted 2017-04-25

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLOD
Date Initiated2017-04-13
Date Terminated2019-03-26
Product Quantity4238

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.

Firm Action

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

Distribution Pattern

TX. Japan Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091908M3 MONITORSpectrum Medical , Ltd. · 2009-07-10K051496COBALT BONE CEMENTBiomet, Inc. · 2005-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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