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Recall Observatory FDA recall evidence

Device 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.

Z-2606-2016

July 26, 2016

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 74800
Status
Terminated
Classification
Class II
Quantity
866 units
Official record key
device-enforcement:Z-2606-2016

Official wording

Reason: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.

Code information: Lot 507970

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled