Events

Recall of Device Recall Dual Port/Single Bladder Disposable Tourniquet Cuff

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Surgical 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
    71575
  • Event Risk Class
    Class 2
  • Event Number
    Z-2349-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138728
  • 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
    Tourniquet, pneumatic - Product Code KCY
  • Reason
    The inside of the folded instructions for use (ifu) pamphlet was missing the usage instructions and warnings.
  • Action
    Zimmer sent an Urgent Medical Device Correction letter dated June 30, 2015, 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, identify the affected product and replace the IFU with the enclosed corrected IFU. Customers were also instructed to complete the attached Response Form and return it via email to CorporateQuality.PostMarket@zimmer.com. Customers with questions were instructed to call 330-364-0989.

Device

Device Recall Dual Port/Single Bladder Disposable Tourniquet Cuff
  • Model / Serial
    Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.
  • Product Description
    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
  • Manufacturer
    Zimmer Surgical Inc

Manufacturer

Zimmer Surgical Inc
  • Manufacturer Address
    Zimmer Surgical Inc, 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