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
Product summary
- 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
mislabeled