Z-0613-2007

Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32

Name: Z-0613-2007 Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
Creator: Gyrus ACMI Corporation
Published: 2007-02-19
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2007-02-19 / Terminated / root cause: packaging

FDA source

Gyrus ACMI Corporation began a recall of Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 on 2007-02-19. The reason FDA records is "Product sterility may be compromised due to failure of the tray seal packaging". 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-0613-2007
Status: Terminated
Initiated: 2007-02-19
Posted: 2007-03-13
Terminated: 2008-02-24
Recalling firm: Gyrus ACMI, Inc.
Product: Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Product sterility may be compromised due to failure of the tray seal packaging
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Gyrus ACMi issued recall letters on 2/19/07. Each account is asked to remove recalled product and return product .
Quantity in commerce: 527 boxes (5 units/box)
Distribution: Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
Product codes and lots: Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012

Product code KNS

K932293Class IICabot Medical Bipolar Cutting ForcepsCabot Medical Corp. / cleared 1994-07-27

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)