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.
FDA Recall Z-2606-2016 · Posted 2016-08-19
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLOD
Date Initiated2016-07-26
Date Terminated2017-01-13
Product Quantity866 units
Reason for Recall
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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