Events

Recall of Device Recall Pulsavac

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

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
    46206
  • Event Risk Class
    Class 2
  • Event Number
    Z-0863-2008
  • Event Initiated Date
    2007-12-18
  • Event Date Posted
    2008-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66975
  • 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
    Jet Lavage - Product Code FQH
  • Reason
    Sterility (package integrity) compromised; the effect of a silicone stain produced during assembly operations on the sterility barrier properties of the tyvek lids has not been validated by the firm.
  • Action
    Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.

Device

Device Recall Pulsavac
  • Model / Serial
    Lot Numbers: 60680331, 60708447, 60715494, 60733561, 60778403, 60795147, 60835632.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Product Description
    Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products

Manufacturer

Zimmer Orthopaedic Surgical Products
  • Manufacturer Address
    Zimmer Orthopaedic Surgical Products, 200 W Ohio Ave, Dover OH 44622-9642
  • 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