Recall Z-2606-2016— Encore Medical, Lp

Name: FDA recall Z-2606-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-26

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2016-07-26, terminated 2017-01-13. It names one FDA 510(k) clearance: K051496. 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: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2016-07-26
Terminated: 2017-01-13
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K051496 — COBALT BONE CEMENTBiomet, Inc.·cleared 2005-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.