Events

Recall of Southmedic/Personna Safety Scalpel

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
    56963
  • Event Risk Class
    Class 2
  • Event Number
    Z-0990-2011
  • Event Initiated Date
    2010-09-03
  • Event Date Posted
    2011-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95060
  • 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
    One-Piece Scalpel - Product Code GDX
  • Reason
    Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
  • Action
    On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.

Device

Southmedic/Personna Safety Scalpel
  • Model / Serial
    Lot numbers: 070910, 081610, 90110, 91410, and 93010.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of TX, MO, NJ, LA, IL, NY, KY, PA, VA, WA, CA, MA, MD, IN, NV, TN, NC, AZ, IA, WI, UT, NE, GA, FL, MN, ME, OH, SD, and KS and countries of Australia and Canada.
  • Product Description
    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.
  • Manufacturer
    Southmedic, Inc.

Manufacturer

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