Events

Recall of Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, 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
    76824
  • Event Risk Class
    Class 2
  • Event Number
    Z-1850-2017
  • Event Initiated Date
    2017-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154328
  • 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
    Bit, surgical - Product Code GFG
  • Reason
    Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.
  • Action
    Smith &n; Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.

Device

Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM
  • Model / Serial
    Batch Numbers: G11227,G18820
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
  • Product Description
    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM || Product Number: 72204049 || The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 130 & 120 Forbes Blvd, Mansfield MA 02048
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA