Recall Z-2606-2016
Encore Medical, Lp · initiated July 26, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 507970
Reason for recall
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-2606-2016
- Initiated
- July 26, 2016
- Posted by FDA
- August 19, 2016
- Terminated
- January 13, 2017
- Product code
- LOD – Bone Cement
- Quantity
- 866 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Encore Medical, Lp, Austin, TX