Gynex Corporation: Medical Device Recall in 2012 - (Recall #: Z-0008-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: September 6, 2012

Date Posted: October 10, 2012

Recall Number: Z-0008-2013

Event ID: 63253

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.

Status: Terminated

Product Quantity: 19 boxes (containing 12 electorde hand pieces each)

Code Information:

Manufacturer's lot number: 54-12-2-21-12.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated