Events

Recall of Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm

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

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
    74224
  • Event Risk Class
    Class 2
  • Event Number
    Z-2084-2016
  • Event Initiated Date
    2016-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146870
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Reason
    The affected k-wires do not meet specification requirements. specifically, a) k-wires were made of 316lvm stainless steel instead of 304 stainless steel. b) k-wires have passivated surface finish instead of electro-polish surface finish. c) k-wires have incorrect length and diameter.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.

Device

Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm
  • Model / Serial
    Lot 237830TE
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
  • Product Description
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System || The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.