Events

Recall of Radial Osteotome Blade

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
    78429
  • Event Risk Class
    Class 2
  • Event Number
    Z-0406-2018
  • Event Initiated Date
    2017-10-23
  • 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=159544
  • 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
    Instrument, manual, surgical, general use - Product Code MDM
  • Reason
    The expiration date provided on the label is incorrect.
  • Action
    The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to FieldActions@smith-nephew.com.

Device

Radial Osteotome Blade
  • Model / Serial
    Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
  • Product Description
    Radial Osteotome Blade, REF 71369314. || Used for cutting or preparing bone.
  • 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