Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components
FDA device recall Z-2606-2016 · posted 2016-08-19 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LOD
- Quantity affected
- 866 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-07-26
- Date posted
- 2016-08-19
- Date terminated
- 2017-01-13
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBALT BONE CEMENT (K051496) | Biomet, Inc. | 2005-08-04 |