Z-2171-2011

Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South...

Name: Z-2171-2011 Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South...
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 Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains... on 2011-02-22. The reason FDA records is "Outer box of Monitoring Kit was mislabeled with the incorrect part 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-2171-2011
Status: Terminated
Initiated: 2011-02-22
Posted: 2011-05-10
Terminated: 2011-05-10
Recalling firm: Integra LifeSciences Corporation
Product: Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: Outer box of Monitoring Kit was mislabeled with the incorrect part number.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified. For any questions regarding this recall call 609-936-2485.
Quantity in commerce: 45 kits
Distribution: Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.
Product codes and lots: Lot number 170314.

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)