Events

Recall of Device Recall Persona Anterior Referencing Sizer with Locking Boom

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
    70676
  • Event Risk Class
    Class 2
  • Event Number
    Z-1360-2015
  • Event Initiated Date
    2015-03-10
  • Event Date Posted
    2015-04-01
  • 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=134474
  • 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
    Zimmer, inc is voluntarily recalling 22 lots of persona¿ anterior referencing sizer with locking boom, part number 42-5099-088-10. devices are being removed from distribution due to nonconforming to print specifications.
  • Action
    Zimmer sent an Urgent Medical device recall letter to all customers on March 10, 2015, via letter and email. The letter identified the product, the problem, and the action to be taken by the customer. Affected units will be inspected. Units that fail inspection will be physically destroyed/scrapped. Units that pass inspection will be re-etched and redistributed. If after reviewing this notification customers have further questions or concerns they were instructed to call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8:00 a.m. through 5:00 p.m. EST. For questions regarding this recall call 574-372-4487.

Device

Device Recall Persona Anterior Referencing Sizer with Locking Boom
  • Model / Serial
    Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
  • Product Description
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom || The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
  • 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