Events

Recall of Device Recall Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc., Endoscopy Div..

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
    32590
  • Event Risk Class
    Class 2
  • Event Number
    Z-0371-06
  • Event Initiated Date
    2005-07-01
  • Event Date Posted
    2006-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40399
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    Drill does not contain laser etched depth marks to assure proper depth of inserted device.
  • Action
    Smith & Nephew notified accounts by Federal Express 07/01/2005 . Accounts are requested tor return units. Sales representatives notified by email.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Lot Number: 50102446
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    NC, PR
  • Product Description
    Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) || Reference Number: 7210430
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • Manufacturer Address
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048-1145
  • Source
    USFDA