Z-2435-2019Class II

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and...

Name: Z-2435-2019 Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and...
Creator: Integra LifeSciences Corp.
Published: 2019-08-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2019-08-07 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332 on 2019-08-07. FDA classified it as Class II and gives the reason as "A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage...". 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-2435-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Posted: 2019-08-30
Terminated: 2020-06-24
Recalling firm: Integra LifeSciences Corporation
Product: Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Product code: DXC Clamp, Vascular
Reason for recall: A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra LifeSciences notified consignees (Hospitals, Distributors) by letter delivered via FedEx on August 7, 2019. Letter states reason for recall, health risk and action to take: 1. Review your inventory and determine if you have any impacted lots listed above.2. If you do have product with an affected Lot Number, stop using the product immediately and remove the product from service. 3. Complete the attached form. If you do not have affected product, check the box, I do not have any product with the lot number. 4. If you do have affected product, check the box I do have product(s) with the lot number. Record the total quantity of affected product you have.5. Complete the other information and Return the completed Acknowledgement and Return Form by email or fax indicating your receipt and review of this notification. Keep a copy of the form for your records. Questions contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401.
Quantity in commerce: 237 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot #AA1901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2435-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2435-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code DXC

K102048Class IIAtraumatic Vascular ClampsGeomed Medizin-Technik GmbH & Co. KG / cleared 2010-11-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)