Events

Recall of Device Recall DRAD SelfTapping Locking Screw

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
    79515
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-2018
  • Event Initiated Date
    2018-03-07
  • Event Date Posted
    2018-03-20
  • 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=162539
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    One lot of d-rad self-taping locking screws used with the distal radius fracture kit were machined out of specification. screws measured over tolerance within the head thread form by 0.002-0.003 inch.
  • Action
    The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.

Device

Device Recall DRAD SelfTapping Locking Screw
  • Model / Serial
    Lot Number 17GM04522
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US, Puerto Rico, Malaysia
  • Product Description
    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew; D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA