Events

Recall of Device Recall NexGen Precoat Stemmed Tibia/NexGen Nonaugmentable Tibial Component

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Manufacturing B.V..

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
    72750
  • Event Risk Class
    Class 2
  • Event Number
    Z-0590-2016
  • Event Initiated Date
    2015-12-03
  • Event Date Posted
    2016-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142123
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    A product complaint was received stating that a carton labeled as a precoat stemmed tibia size 3 was opened for use and the contents were a non-augmented stemmed tibia plate size 3.
  • Action
    Zimmer Biomet sent an "Urgent Medical Device Recall-Lot Specific" letter to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1). Email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 4. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1). Clearly mark the outside carton of each product return shipment made as Recall. 5. Please notify Zimmer Biomet of any hospitals to which you have further distributed the affected product. Supply the information for any hospitals that you have identified, as well as the affected surgeons, using the provided spreadsheet template. The template will be emailed to you for completion. Please return to corporate quality.postmarket@zimmerbiomet.com. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

Device

Device Recall NexGen Precoat Stemmed Tibia/NexGen Nonaugmentable Tibial Component
  • Model / Serial
    lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
  • Product Description
    NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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