Events

Recall of Device Recall Articulated Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exactech, 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
    65568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1832-2013
  • Event Initiated Date
    2013-05-30
  • Event Date Posted
    2013-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119601
  • 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
    Driver, surgical, pin - Product Code GFC
  • Reason
    When torque is applied to the articulated driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.
  • Action
    Exactech sent a" Important Product Recall Notice" dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to Immediately cease distribution or use of the products. Extend this information to your accounts that may have this product in their possession. Verify if you have any of the subject ARTICULATE DRIVER (catalog number 181-00-04) in the specified lots. FAx back the attached form. Further questions please call 1-800-392-2832.

Device

Device Recall Articulated Driver
  • Model / Serial
    Lot #: 52667001 Catalog #: 181-00-04
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AR, CA, FL, NJ, NY, OK, and TX
  • Product Description
    Exactech Articulated Driver || A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA