Events

Recall of Device Recall Southmedic Sterile Disposable Scalpel Rx only

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southmedic, 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
    80074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1892-2018
  • Event Initiated Date
    2017-11-06
  • 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=164365
  • 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
    Scalpel, one-piece - Product Code GDX
  • Reason
    Scalpels lot contains non-sterile products labeled as sterile.
  • Action
    On November 6th, 2017 , Southmedic sent notification to all their customers stating that: Southmedic Inc. is conducting a voluntary recall of a specific lot number of the Southmedic Sterile Disposable Scalpel (73-0115) Lot#: 092517 due to an incorrect sterility status having been identified on the label. This may result in non-sterile products being labeled as sterile. After checking your inventory, please complete the attached Voluntary Recall Notification Confirmation Form and fax to (705) 728 9537. We apologize for any inconvenience this action may cause. Your immediate attention is appreciated. We apologize for any inconvenience this action may cause. Your immediate attention is appreciated. For product return questions please contact Customer Service at (800) 463- 7146 ext 307.

Device

Device Recall Southmedic Sterile Disposable Scalpel Rx only
  • Model / Serial
    Part Number 73-0115 Lot Number 092517
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : IA, IL, NE, NY and TX
  • Product Description
    Southmedic Sterile Disposable Scalpel Rx only || Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
  • Manufacturer
    Southmedic, Inc.

Manufacturer

Southmedic, Inc.
  • Manufacturer Address
    Southmedic, Inc., 50 Alliance Blvd, Barrie Canada
  • Manufacturer Parent Company (2017)
    Southmedic, Inc.
  • Source
    USFDA