Events

Recall of Device Recall A.T.S. 4000TS Tourniquet Systems, Personalized Pressure

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
    78759
  • Event Risk Class
    Class 2
  • Event Number
    Z-0612-2018
  • Event Initiated Date
    2017-07-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160466
  • 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
    Updated on-device label and 3 pages of an updated operator/service manual. also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and rf communication equipment.
  • Action
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE CORRECTIONS" letter dated 7/27/2017 to its customers via email or mail. The letter describes the product, problem and actions to be taken. Instructions for distributors include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, review the hospital list of customers that accompanied the notice and return contact information for any additional hospitals product was distributed to. Instructions for Risk Managers at hospitals include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, and complete and return the Attachment 1 form via email to corporatequality.postmarket@zimmerbiomet.com or ZimmerBiomet8287@stericycle.com or fax to 866-338-2611. If after reviewing this notification you have further questions or concerns please call +1(330) 364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency.

Device

Device Recall A.T.S. 4000TS Tourniquet Systems, Personalized Pressure
  • Model / Serial
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..
  • Product Description
    A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. || Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. || .
  • 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