Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin) Recalled by Zimmer, Inc. Due to The patient label associated with the product may...

Date: November 4, 2013
Company: Zimmer, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.

Affected Products

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.

Quantity: 1,534 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer, Inc.

Zimmer, Inc. has 437 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report