Events

Recall of Device Recall CROSSCHECK(R) Plating system, Utility Plate, 4Hole, REF CCPUTN4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology, 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
    70859
  • Event Risk Class
    Class 2
  • Event Number
    Z-1496-2015
  • Event Initiated Date
    2015-03-06
  • Event Date Posted
    2015-04-22
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135256
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    The minor diameter, major diameter, thread pitch, and pitch on the crosscheck are out of specification, which may result in intraoperative malfunction.
  • Action
    Firm has initiated the recall on 03/06/2015 through written communication via Fed Ex P1 delivery to all Wright Medical Technologies distributors (hubs). Follow-up to non-responding consignees will commence 30 days after initiation. Effectiveness checks will be performed through the confirmation of returned product via a validated ERP system, a returned/signed verification form, and in the case of non-responders, a phone call, e-mail or follow up letter, depending on the region and availability of consignee.

Device

Device Recall CROSSCHECK(R) Plating system, Utility Plate, 4Hole, REF CCPUTN4
  • Model / Serial
    Lot Numbers: 3504931, 35049-31A, 35049-31A-1, 35049-32, 362803, 36280-3-1, 8752-010381
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. || Orthopedic use.
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • Manufacturer Address
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA