Events

Recall of The 2nd Assist Knee Positioner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet, 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
    79141
  • Event Risk Class
    Class 2
  • Event Number
    Z-0803-2018
  • Event Initiated Date
    2017-09-07
  • 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=161434
  • 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
    Table, surgical with orthopedic accessories, manual - Product Code JEB
  • Reason
    Zimmer biomet is conducting a medical device recall for the 2nd assistant knee positioner due to the potential for the sterile packaging barrier to be breached during distribution.
  • Action
    On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071

Device

The 2nd Assist Knee Positioner

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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