Events

Recall of Device Recall VALOR(R) Nail, Right, Small

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
    79581
  • Event Risk Class
    Class 2
  • Event Number
    Z-1376-2018
  • Event Initiated Date
    2018-03-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162692
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Tow lot of valor(tm) nail could potentially be missing the assembled compression screw.
  • Action
    Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.

Device

Device Recall VALOR(R) Nail, Right, Small
  • Model / Serial
    Lot 1610957
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
  • Product Description
    WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • Manufacturer Address
    Wright Medical Technology, Inc., 11576 Memphis Arlington Rd, Arlington TN 38002-9497
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA