Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides… — Class II medical device recall Z-2606-2016
Terminated recall by Encore Medical, Lp, reported 2016-08-31, distributed nationwide. The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not
| Recall number | Z-2606-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2016-07-26 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 866 units |
| Reason classes | labeling |
| Lot numbers | 507970 |
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.
Reason for recall
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2606-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.