Events

Recall of Persona

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, 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
    69039
  • Event Risk Class
    Class 2
  • Event Number
    Z-2737-2014
  • Event Initiated Date
    2014-09-09
  • Event Date Posted
    2014-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129382
  • 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
    Driver, surgical, pin - Product Code GFC
  • Reason
    The persona 48mm x 2.5mm female screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm persona hex driver.
  • Action
    Zimmer sent an URGENT MEDICAL DEVICE RECALL notifications dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review the notification and the updated portion of the Persona surgical technique provided in Attachment 1, and ensure affected personnel are aware of the contents. 2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Device

Persona
  • Model / Serial
    Lot Numbers:  62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
  • Product Description
    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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