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.
Recall
- Recall Number
- Z-2606-2016
- Event Number
- 74800
- FEI Number
- 1000116912
- Product Code
- LOD
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- July 26, 2016
- Posted
- August 19, 2016
- Terminated
- January 13, 2017
- Address
- 9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445
Description
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.
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
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.
US Nationwide Distribution
866 units