Events

Recall of 100 mL Hemovac Mini Evacuator

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
    71057
  • Event Risk Class
    Class 3
  • Event Number
    Z-1610-2015
  • Event Initiated Date
    2015-04-21
  • Event Date Posted
    2015-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135958
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    Devices were placed in a shipper carton without the appropriate number of the instructions for use (ifu). packaging specifications require that each sales unit is accompanied by an ifu. only one ifu was present in the shipper carton, instead of one ifu per each of the two sales units.
  • Action
    On 4/28/2015 the firm sent Urgent: Medical Device Removal letters to their customers. The letters identified the affected product in addition to stating that the reason for the recall is due to missing Instructions for Use from sales units. The letters discussed the clinical implications or risk to health, and actions required. Customers are to review the notification, identify and quarantine the affected product to prevent further distribution or use, and return the completed response form to CorporateQuality.PostMarket@zimmer.com and the affected product to the address provided. A credit will be issued for unused devices upon receipt. Questions regarding this information should be directed to 330-364-0989.

Device

100 mL Hemovac Mini Evacuator
  • Model / Serial
    Item #00-2568-000-10; Lot #62800843
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
  • Product Description
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. || Intended for post-operative collection of wound drainage.
  • 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