Recall Z-0008-2013— Gynex Corporation

Class III FDA medical device recall by Gynex Corporation, initiated 2012-09-06, terminated 2012-10-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Gynex Corporation

Classification

Class III

Status

Terminated

Initiated

2012-09-06

Terminated

2012-10-22

Firm location

Redmond, WA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.