Events

Recall of Device Recall Miltex Premium Grade SelfLocking Chisel Blade Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra York PA, 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
    74079
  • Event Risk Class
    Class 2
  • Event Number
    Z-1841-2016
  • Event Initiated Date
    2016-03-11
  • Event Date Posted
    2016-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146227
  • 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
    Surgical Chisel Handle - Product Code GDZ
  • Reason
    One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
  • Action
    Integra mailed out an Urgent: Voluntary Medical Device Recall letter to customers informing them to evaluate their inventory for the affected product. If product was shipped to customers, they were asked to identify their customers and to stop shipping immediately. Integra requested that customers complete the attached form that was sent with the notification indicating whether or not they had the affected product on hand and customer service will contact them to provide a Return Authorization number for the product's return. Customers could reach Customer Service at 866-854-8300.

Device

Device Recall Miltex Premium Grade SelfLocking Chisel Blade Handle
  • Model / Serial
    Catalogue No. 4-405, Lot # 97327
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Mexico, and Korea.
  • Product Description
    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
  • Manufacturer
    Integra York PA, Inc

Manufacturer

Integra York PA, Inc