Recall Z-0730-2014— Zimmer, Inc.

Name: FDA recall Z-0730-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-04

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-11-04, terminated 2014-10-08. It names one FDA 510(k) clearance: K031673. Product: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.. Reason: The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Terminated: 2014-10-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K031673 — REFOBACIN -PALACOS GHeraeus Kulzer GmbH & Co. KG·cleared 2004-05-25

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

Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Reason for recall

The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

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