Events

Recall of Device Recall Zimmer PSI Knee Persona" Jigs (Patient Specific Instrumentation)

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

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
    69630
  • Event Risk Class
    Class 2
  • Event Number
    Z-0495-2015
  • Event Initiated Date
    2014-11-03
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131197
  • 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
    Internal discovery found that the mri scans in some psi knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
  • Action
    The firm, Zimmer CAS, sent an "URGENT: MEDICAL DEVICE NOTIFICATION" dated November 3, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to read this notice and be familiar with its contents; complete and return the attachment 1 CERTIFICATE OF ACKNOWLEDGEMENT form via fax to Zimmer Inc. at (574) 372-4265 or scan and email to corporatequality.postmarket@zimmer.com; and maintain a copy of the completed attachment 1 for your files. If you have questions concerning this notice, please call 514-861-4074 ext 292 or email: jean-sebastien.merette@zimmercas.com

Device

Device Recall Zimmer PSI Knee Persona" Jigs (Patient Specific Instrumentation)
  • Model / Serial
    BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01;  Expiration dates 5/8/14-12/31/15
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in states of: AZ, CO, IL, OR, and WA.
  • Product Description
    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer || The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
  • Manufacturer
    Zimmer CAS

Manufacturer

Zimmer CAS
  • Manufacturer Address
    Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • 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