Z-0008-2013Class III

Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot...

Name: Z-0008-2013 Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot...
Creator: Gynex Corporation
Published: 2012-09-06
License: https://open.fda.gov/license/

Gynex Corporation / initiated 2012-09-06 / Terminated / root cause: manufacturing process

FDA source

Gynex Corporation began a recall of Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part... on 2012-09-06. FDA classified it as Class III and gives the reason as "The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0008-2013
Classification: Class III
Status: Terminated
Initiated: 2012-09-06
Posted: 2012-10-03
Terminated: 2012-10-22
Recalling firm: Gynex Corporation
Product: Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Product code: HGI Electrocautery, Gynecologic (And Accessories)
Reason for recall: The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were first notified by phone with a follow up e-mail or fax. The consignees were asked to complete the response section regarding the destruction/return of the device. For questions regarding this recall call 425-882-1179.
Quantity in commerce: 19 boxes (containing 12 electorde hand pieces each)
Distribution: Nationwide Distribution
Product codes and lots: Manufacturer's lot number: 54-12-2-21-12.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0008-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0008-2013	Class III	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-03

Product code HGI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)