Events

Recall of Device Recall VerSys Femoral Head

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
    56032
  • Event Risk Class
    Class 2
  • Event Number
    Z-2291-2010
  • Event Initiated Date
    2010-07-05
  • Event Date Posted
    2010-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93363
  • 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
    prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Zimmer, inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. in addition, there is a potential for the patient record label to be incorrect.
  • Action
    The firm, Zimmer, Inc., sent an "URGENT: DEVICE REMOVAL" letter dated July 9, 2010, to all consignees. The letter described the issue, clinical implications, affected product, and required actions. The consignees were instructed to carefully review the letter, ensure users of the VerSys Hip System Femoral Head device at their faculty have been informed of this removal and perform a physical count of all affected product at their facility, record the data on the Inventory Return Certification Form and/or the User Facility/HCP Form and return the form via fax at (574) 372-4265 or email: aimee.wood@zimmer.com. Zimmer Inc. will conduct a removal of all remaining (unused) units of the subject lots. For shipping assistance, questions or assistance in notifying your accounts about the device removal, please contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.

Device

Device Recall VerSys Femoral Head
  • Model / Serial
    VerSys¿ Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-028-01; Lot number 61424803.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
  • Product Description
    VERSYS¿ HIP SYSTEM || FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH || ZIMALOY¿ CO-CR-MO ALLOY STERILE QTY-1 || MANUFACTURED BY ZIMMER MANUFACTURING B.V., || A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) || The VerSys¿ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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