Events

Recall of Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Myco Medical Supplies 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
    64434
  • Event Risk Class
    Class 2
  • Event Number
    Z-0891-2013
  • Event Initiated Date
    2013-02-07
  • Event Date Posted
    2013-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116137
  • 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
    Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
  • Action
    MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.

Device

Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.
  • Model / Serial
    Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
  • Product Description
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
  • Manufacturer
    Myco Medical Supplies Inc

Manufacturer

Myco Medical Supplies Inc
  • Manufacturer Address
    Myco Medical Supplies Inc, 158 Towerview Ct, Cary NC 27513
  • Manufacturer Parent Company (2017)
    Myco Medical Supplies Inc.
  • Source
    USFDA