Events

Recall of Gomco Circumcision Clamps with separate ORing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap Implant Systems LLC.

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
    75937
  • Event Risk Class
    Class 2
  • Event Number
    Z-0947-2017
  • Event Initiated Date
    2016-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151777
  • 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
    Clamp, circumcision - Product Code HFX
  • Reason
    Aesculap has received complaints of excessive bleeding after use of gomco circumcision clamps.
  • Action
    Aesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.

Device

Gomco Circumcision Clamps with separate ORing
  • Model / Serial
    Material Code MG096R  (1.1 CM) MG097R  (1.3 CM) MG227 (1.45CM) MG228  (1.6CM) MG229  (2.1 CM) MG230  (2.6CM)
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life || The Gomco clamp is intended to be used for circumcision surgeries
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Manufacturer Address
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA