Events

Recall of Device Recall Zimmer

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
    72900
  • Event Risk Class
    Class 2
  • Event Number
    Z-1124-2016
  • Event Initiated Date
    2016-01-11
  • Event Date Posted
    2016-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143687
  • 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
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • Model / Serial
    lot no.: 61555543 61597965 61670825 62079145 62079148 62124066 62135039 62185960 62203621 62221041 62221043 62221044 62267947 62267949 62267950 62268526 62277492 62277493 62278701 62278702 62278703 62340123 62397828 62397831 62267950N 62278701N 62278702N 62278703N 61597959 61653581 62218170 62265345 62277494 62294359 62218170N 62277494N 62294359N 61292730N 62122127 62267951 62267952 62278704 62267952N 62278704N 62181482 62304835 62304835N 62203622 62203622N 62289044 62391711 62289044N 62391711V 61854615 61977887 62135046 62162460 62267946 62268527 62340121 62268527N 62289054 62289083 62304837 62289054N 62289083N 62304837N
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 26 consists of all product under product code: JWH and same usage: || Item no: || 234703104 DISTAL MEDIAL FEMORAL CON || 234703206 DISTAL MEDIAL FEMORAL CON || 234703208 DISTAL MEDIAL FEMORAL CON || 234800504 DISTAL POSTERIOR/LATERAL || 234800506 DISTAL POSTERIOR/LATERAL || 234800508 DISTAL POSTERIOR/LATERAL || 234800510 DISTAL POSTERIOR/LATERAL || 234800604 DISTAL POSTERIOR/LATERAL || 234800606 DISTAL POSTERIOR/LATERAL || 234800608 DISTAL POSTERIOR/LATERAL || 234800610 DISTAL POSTERIOR/LATERAL || 234800614 DISTAL POSTERIOR/LATERAL || Product Usage: || For use in total or hemi hip arthroplasty
  • 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