Events

Recall of PenBlade Safety Scalpel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zien Medical Technologies, 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
    72038
  • Event Risk Class
    Class 2
  • Event Number
    Z-2800-2015
  • Event Initiated Date
    2015-08-18
  • Event Date Posted
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139641
  • 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
    Cracks were discovered in the pet tray of a small population of sterile product. these cracks create a risk of loss of sterile barrier for the product. sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from september 2014-july 2015. this led to the decision to recall the product.
  • Action
    All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall.

Device

PenBlade Safety Scalpel
  • Model / Serial
    Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to U.S. nationwide, Germany and England.
  • Product Description
    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
  • Manufacturer
    Zien Medical Technologies, Inc

Manufacturer

Zien Medical Technologies, Inc
  • Manufacturer Address
    Zien Medical Technologies, Inc, 2500 S State St, Sted240, Salt Lake City UT 84115-3110
  • Manufacturer Parent Company (2017)
    Zien Medical Technologies Inc.
  • Source
    USFDA