Events

Recall of Device Recall Palacos RG Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copol

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66990
  • Event Risk Class
    Class 2
  • Event Number
    Z-0730-2014
  • Event Initiated Date
    2013-11-04
  • Event Date Posted
    2014-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124437
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone cement, antibiotic - Product Code MBB
  • 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.
  • 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.

Device

Device Recall Palacos RG Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methy...
  • Model / Serial
    Cat No. 00-1113-140-01; lot 75974340
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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 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.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA