Events

Recall of Zimmer Patient Specific Instrument PERSONA CR Pin Guides

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

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
    69632
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2015
  • Event Initiated Date
    2014-10-16
  • Event Date Posted
    2014-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131198
  • 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
    The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. the device did not meet specification: one tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
  • Action
    Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057.

Device

Zimmer Patient Specific Instrument PERSONA CR Pin Guides
  • Model / Serial
    00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to MN only
  • Product Description
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
  • Manufacturer
    Materialise USA LLC

Manufacturer

Materialise USA LLC
  • Manufacturer Address
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • Manufacturer Parent Company (2017)
    Materialise Nv
  • Source
    USFDA