Encore Medical, Lp: Medical Device Recall in 2016 - (Recall #: Z-2606-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 26, 2016

Date Posted: August 31, 2016

Recall Number: Z-2606-2016

Event ID: 74800

Reason for Recall:

The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.

Status: Terminated

Product Quantity: 866 units

Code Information:

Lot 507970

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated