FDA Device Recall Z-0008-2013: Gynex Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-2013.

Recall Res Number

Z-0008-2013

Recalling Firm / Manufacturer

Gynex Corporation

FEI Number

3001238683

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-09-06

Date Posted

2012-10-03

Date Terminated

2012-10-22

Product Code

HGI

Event Number

63253

Product Quantity

19 boxes (containing 12 electorde hand pieces each)

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.

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.

Action Details 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.

Distribution Pattern Nationwide Distribution

Code Information / Serial Numbers Manufacturer's lot number: 54-12-2-21-12.

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Medical Device Recall: Z-0008-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer