Events

Recall of Device Recall SMARTSET GHV Gentamicin Bone Cement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, 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
    70507
  • Event Risk Class
    Class 2
  • Event Number
    Z-1246-2015
  • Event Initiated Date
    2015-02-11
  • Event Date Posted
    2015-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133929
  • 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
    One lot of smartset ghv gentamicin bone cement is partially agglomerated . this may result in surgical delays while a replacement package of cement is retrieved and mixed.
  • Action
    DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am  5 pm EST). For questions regarding this recall call 574-371-4577.

Device

Device Recall SMARTSET GHV Gentamicin Bone Cement
  • Model / Serial
    Cat. No. 545035500, Lot No. 7915797
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.
  • Product Description
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA