Z-2606-2016Class II

Cobalt HV Bone Cement

Name: Z-2606-2016 Cobalt HV Bone Cement
Creator: Encore Medical, Lp
Published: 2016-07-26
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2016-07-26 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque... on 2016-07-26. FDA classified it as Class II and gives the reason as "The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2606-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-26
Posted: 2016-08-19
Terminated: 2017-01-13
Recalling firm: Encore Medical, LP
Product: Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Product code: LOD Bone Cement
Reason for recall: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recalling firm sent an Urgent Field Safety Notice letter dated July 26 2016 to Sales Agents. The letter identified the affected product, problem and actions to be taken. The sales agents were instructed to pass on the notice to any organization where the potential affected product has been transferred. Agents were instructed to identify hospitals in their territory, complete a visually inspection of the affected product in the hospital's inventory, complete an Acknowledgement and Receipt form. If affected products is found contact Customer Service at 1-800-456-8696 for replacement.
Quantity in commerce: 866 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot 507970

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2606-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2606-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code LOD

K051496Class IICobalt Bone CementBiomet, Inc. / cleared 2005-08-04

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)