Z-1719-2014Class II

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient...

Name: Z-1719-2014 MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient...
Creator: ConMed Corporation
Published: 2014-05-08
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2014-05-08 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a... on 2014-05-08. FDA classified it as Class II and gives the reason as "ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed". 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-1719-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Posted: 2014-06-04
Terminated: 2017-04-11
Recalling firm: ConMed Corporation
Product: MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ConMed sent an Urgent Medical Device Recall letter dated May 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective Action: All returned devices will be received into the facility and the lot number and quantity recorded on to an electronic spreadsheet. The returned product will then be stored in a secure quarantined area. At this time, management has not determined as to how the devices will be dispositioned. A protocol(s) will be written to address the destruction of the returned devices. This will be submitted to NYK-DO for approval prior to any action being taken with the returned devices. CAPA 153136 was opened. Fixtures were revised to allow for placement of the foil/gel substrate from the bottom of the foam. This is to maintain consistent dimensions on the product and not allow for float/movement of the substrate from being offset. For further questions please call (315) 624-3024 or fax to (315) 624-3030.
Quantity in commerce: Domestic - 12,600 units, Foreign - 44,280 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
Product codes and lots: Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1719-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1719-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code GEI

K120476Class IIMacrolyte Dispersive ElectrodeConmed Corporation / cleared 2012-06-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)