Z-2194-2011

Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT...

Name: Z-2194-2011 Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT...
Creator: Integra LifeSciences Corp.
Published: 2011-02-22
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-02-22 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing... on 2011-02-22. The reason FDA records is "Outer packaging of Combo Kit was mislabeled with an incorrect lot number". 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-2194-2011
Status: Terminated
Initiated: 2011-02-22
Posted: 2011-05-13
Terminated: 2011-05-13
Recalling firm: Integra LifeSciences Corporation
Product: Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.
Quantity in commerce: 7 Kits
Distribution: Nationwide Distribution -- including the state of New York.
Product codes and lots: Lot 171237

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