Encore Medical product recalled over labeling errors

Recall date

July 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Encore Medical, Lp recalls Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized component…

Recall number

Z-2606-2016

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.