Z-1301-04

ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula...

Name: Z-1301-04 ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula...
Creator: Conmed Corporation
Published: 2004-06-28
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2004-06-28 / Terminated

FDA source

Conmed Corporation began a recall of ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 -... on 2004-06-28. The reason FDA records is "Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1301-04
Status: Terminated
Initiated: 2004-06-28
Posted: 2004-07-31
Terminated: 2005-10-05
Recalling firm: ConMed Corporation
Product: ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.
FDA root cause: Other
Action: Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
Quantity in commerce: 3,252 units
Distribution: Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
Product codes and lots: Cat. #60-5158-034 with lot #s 0310301, 0402031, 0403051, 0404131; Cat. # 60-5158-234 with lot # 0310081; Cat. #60-5158-432 with lot #s 0310081, 0310301, 0311101, 0401051, 0401121, 0402031, 0403051, 0411121; Cat. # 60-5158-934 with lot #s 0311101, 0401121.

Product code GEI

K960808Class IIConmed Select One Laparoscopy ElectrodeConmedcorp / cleared 1996-03-21

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)