Z-2056-2017Class II

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

Name: Z-2056-2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Creator: Zimmer Biomet, Inc.
Published: 2017-04-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-04-13 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin on 2017-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2056-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2017-04-25
Terminated: 2019-03-26
Recalling firm: Zimmer GmbH
Product: Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Product code: LOD Bone Cement
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.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 4238
Distribution: TX. Japan Mexico
Product codes and lots: Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin 402438 Lot: 507830 402282J Lot: 668140 402282 Lot: 508220 402283J Lot: 189780

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2056-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2056-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-09

Product code LOD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)