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Terminated

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.

FDA Recall Z-0008-2013 · Posted 2012-10-03

Recalling FirmGynex Corporation
Recall StatusTerminated
Product CodeHGI
Date Initiated2012-09-06
Date Terminated2012-10-22
Product Quantity19 boxes (containing 12 electorde hand pieces each)

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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