Z-2606-2016 Class II Terminated
FDA device recall Z-2606-2016 was initiated by Encore Medical, Lp on Jul 26, 2016 and is designated Class II. Reason for recall: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics. The recall status is terminated (terminated Jan 13, 2017). Affected quantity: 866 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jul 26, 2016
- Termination Date
- Jan 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 866 units
Product 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.
Reason for recall
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
Distribution pattern
US Nationwide Distribution
Code information
Lot 507970
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2606-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026