Events

Recall of GYRUS ACMI, dissector PlasmaKnife

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

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
    56304
  • Event Risk Class
    Class 2
  • Event Number
    Z-2651-2010
  • Event Initiated Date
    2010-08-06
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93171
  • 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 - Product Code GEI
  • Reason
    Lack of sterility assurance due to compromised package seals.
  • Action
    The firm initiated their recall to their direct accounts by Priority Mail with delivery confirmation on 08/06/2010. The letter requested return of the product and was extended to the retail level.

Device

GYRUS ACMI, dissector PlasmaKnife
  • Model / Serial
    All lots manufactured from June 1, 2007 through June 7, 2010.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide In the United States: AL, AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and the District of Columbia. Foreign: UK, TAIWAN, SOUTH KOREA, GERMANY, CANADA, AUSTRALIA, SPAIN, ITALY, ISRAEL, NORWAY, LITHUANIA, SWEDEN, SWITZERLAND, SAUDI ARABIA, TURKEY, and GREAT BRITAIN
  • Product Description
    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Manufacturer Address
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA