Z-1201-2024Class II

Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles...

Name: Z-1201-2024 Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles...
Creator: Integra LifeSciences Corp.
Published: 2024-01-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-01-19 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain on 2024-01-19. FDA classified it as Class II and gives the reason as "A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1201-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-19
Posted: 2024-02-28
Recalling firm: Integra LifeSciences Corporation
Product: Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall letter on 01/19/24 via fedex overnight. Letter states reason for recall, health risk and action to take: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 3. Forward this notice to those who utilize the device so they are aware of this recall and can identify any affected devices that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit or a replacement for the quantities returned (based on inventory availability). Actions to be Taken by Distributors/Sales Reps: 1. If you do have the affected product listed in Table 1, remove the product from further distribution. 2. Complete the attached Acknowledgment Form. 3. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. 4. If you do not have affected product, check the box, I do not have affected product. 5. After completion, please email the Acknowledgement Form to [email protected] or FAX to 1-609-750-4220. 6. Keep a copy of the form for your records. 7. Please check your customer traceability records for shipments of above catalog and lot numbers. 8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog
Quantity in commerce: 8906 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
Product codes and lots: UDI: 10381780263968 Lot Number Exp: Date: 6631603 1-Sep-23 6631604 1-Sep-23 6710212 1-Sep-23 6710213 1-Sep-23 6788598 1-Sep-23 6788599 1-Dec-23 6788600 1-Jan-24 6896383 1-Dec-23 6896384 1-Jan-24 6896385 1-Jan-24 6955153 17-Mar-24 6955154 17-Mar-24 6955155 17-Mar-24 7000260 17-Mar-24 7000261 17-Mar-24 7000262 17-Mar-24 7028225 17-Mar-24 7028226 17-Mar-24 7028227 1-Apr-24 7073035 1-Apr-24 7073036 1-Apr-24 7073037 1-Apr-24 7124699 1-Apr-24 7124700 1-Apr-24 7124702 1-Apr-24 7249008 1-Jun-24 7249009 1-Jun-24 7257038 1-Jun-24 7257039 1-Jun-24 7257040 1-Jun-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1201-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1194-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1195-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1196-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1197-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1198-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1199-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1200-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1201-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1202-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28
Z-1203-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-28

Product code HBG

K961113Class IICns Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC / cleared 1996-06-05

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)