Events

Recall of Device Recall INSORB 2030 Subcuticular Skin Stapler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Incisive Surgical 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
    70906
  • Event Risk Class
    Class 2
  • Event Number
    Z-1545-2015
  • Event Initiated Date
    2015-03-19
  • Event Date Posted
    2015-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135495
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    A previous turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. the expiration date at the time of manufacturing was 2014-05.
  • Action
    Firm is working with EU Rep on English and Turkish notification letters.

Device

Device Recall INSORB 2030 Subcuticular Skin Stapler
  • Model / Serial
    Lot 121901
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution Only - Turkey.
  • Product Description
    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
  • Manufacturer
    Incisive Surgical Inc

Manufacturer

Incisive Surgical Inc
  • Manufacturer Address
    Incisive Surgical Inc, 14405 21st Ave N, Plymouth MN 55447-4685
  • Manufacturer Parent Company (2017)
    Incisive Surgical Inc.
  • Source
    USFDA