Z-2028-2012Class II

Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic...

Name: Z-2028-2012 Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic...
Creator: Integra Limited
Published: 2012-05-23
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2012-05-23 / Terminated / root cause: manufacturing process

FDA source

Integra Limited began a recall of Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic... on 2012-05-23. FDA classified it as Class II and gives the reason as "The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification". 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-2028-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-23
Posted: 2012-07-18
Terminated: 2013-03-19
Recalling firm: Integra Lifesciences Sales LLC
Product: Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
Product code: KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Reason for recall: The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm. We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.
Quantity in commerce: 108
Distribution: USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
Product codes and lots: Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2028-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2028-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-18

Product code KNF

K103726Class IIJarit Take-Apart Endoscopic InstrumentsIntegra LifeSciences Corporation / cleared 2012-02-08

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)