Z-0886-2013Class II

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a...

Name: Z-0886-2013 Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a...
Creator: Integra LifeSciences Corp.
Published: 2013-02-12
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-02-12 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or... on 2013-02-12. FDA classified it as Class II and gives the reason as "Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0886-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-12
Posted: 2013-02-26
Terminated: 2013-12-24
Recalling firm: Integra LifeSciences Corporation
Product: Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
Product code: KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Reason for recall: Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Integra sent an Urgent Medical Device Correction Field Safety Notice letter dated February 12, 2013 and a copy of the Instructions for Use addendum to all affected customers. The letter identified the product, nature of the issue and actions to be taken. Customers were requested to examine their inventory for the affected product and include a copy of the addendum to that inventory. Customers were instructed to complete and return the Acknowledgement Return Form and provide a copy of the IFU addendum to any of their customers that had purchased the Jarit(R0 Monopolar Cable. For questions call Integra Surgical Customer Service at 800-431-1123.
Quantity in commerce: 22,500
Distribution: Worldwide Distribution - USA Nationwide including Canada.
Product codes and lots: Catalogue No. 600-290. All lots distributed since 2004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0886-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code KNF

K932456Class IIJarit Surgical InstrumentsJ. Jamner Surgical Instruments, Inc. / cleared 1994-04-21

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)