Events

Recall of Gyrus ACMI PKS Seal Open Forceps.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus ACMI Corporation.

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
    53890
  • Event Risk Class
    Class 2
  • Event Number
    Z-0637-2010
  • Event Initiated Date
    2009-08-18
  • Event Date Posted
    2010-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86816
  • 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
    Electrosurgical cutting and coagulation device and accessories. - Product Code GEI
  • Reason
    Gyrus acmi received complaints of a problem with 3103pk, 3104pk, 3105pk, 915000pk, 915005pk, 915010pk - gyrus acmi pks seal open forceps. the metal shim between the jaws may detach during the procedure and fall into the surgical field. the detached shim may be undetected and be left behind in the patient. this circumstance could subsequently cause complications. further use of this product sh.
  • Action
    An Urgent Medical Device Recall letter, dated 08/15/09 was sent to customers notifying them of the issue. The letter identified affected product, asked that they cease further use, remove affected devices from stockrooms, contact Gyrus ACMI customer service for a return goods authorization and return product to Gyrus ACMI at no charge. A reply form is also asked to be returned to Gyrus ACMI via fax. Questions and requests for a Return Goods Authorization are directed to Gyrus ACMI customer service at 1-888-524-7266.

Device

Gyrus ACMI PKS Seal Open Forceps.
  • Model / Serial
    all lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
  • Product Description
    Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
  • Manufacturer
    Gyrus ACMI Corporation

Manufacturer

Gyrus ACMI Corporation
  • Manufacturer Address
    Gyrus ACMI Corporation, 136 Turnpike Rd, Southborough MA 01772-2118
  • Source
    USFDA