Z-2651-2010

GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR...

Name: Z-2651-2010 GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR...
Creator: Gyrus Acmi, Incorporated
Published: 2010-08-06
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2010-08-06 / Terminated / root cause: packaging

FDA source

Gyrus Acmi, Incorporated began a recall of GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD... on 2010-08-06. The reason FDA records is "Lack of sterility assurance due to compromised package seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2651-2010
Status: Terminated
Initiated: 2010-08-06
Posted: 2010-09-30
Terminated: 2012-01-26
Recalling firm: Gyrus ACMI, Inc.
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Lack of sterility assurance due to compromised package seals.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 4244 units
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 codes and lots: All lots manufactured from June 1, 2007 through June 7, 2010.

Product code GEI

K041285Class IIGyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)Gyrus Medical , Ltd. / cleared 2004-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)