Recall Z-2606-2016 ยท LOD Bone Cement
Encore Medical, Lp
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.
| Date | Aug 19, 2016 (initiated Jul 26, 2016) |
| Status | Terminated |
| Reason | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics. |
| 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 | 866 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051496 | COBALT BONE CEMENT Biomet, Inc., Aug 4, 2005 |