FDA Device recall Z-0730-2014
Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer…
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer… by Zimmer, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0730-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-04 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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.
Identifiers
| code_info | Cat No. 00-1113-140-01; lot 75974340 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0730-2014%22
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