Z-0730-2014Class II

Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20...

Name: Z-0730-2014 Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20...
Creator: Zimmer, Inc.
Published: 2013-11-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-11-04 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a 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 0.5 g Gentamicin... on 2013-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0730-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Posted: 2014-01-13
Terminated: 2014-10-08
Recalling firm: Zimmer GmbH
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.
Product code: MBB Bone Cement, Antibiotic
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Zimmer sent an Urgent Device Removal letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, idetntify the product and remove from use. If the affected product has been utilized, follow institutional protocol to determine if it is appropriate to place a copy of the notification letter into patient records for the affected product. Complete the attached Response Form and return it via fax to 800-871-7270. Customers were instructed to return a copy of the completed response form along with their returned product to ensure proper credit. Customers with questions were instructed to call 866-608-3941. For questions regarding this recall call 800-613-6131.
Quantity in commerce: 1,534 units
Distribution: Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.
Product codes and lots: Cat No. 00-1113-140-01; lot 75974340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0730-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0730-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-13

Product code MBB

K031673Class IIRefobacin -Palacos GHeraeus Kulzer GmbH & Co. KG / cleared 2004-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)