Z-0749-2012

Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents...

Name: Z-0749-2012 Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2011-12-21
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2011-12-21 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and... on 2011-12-21. The reason FDA records is "Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine". 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-0749-2012
Status: Terminated
Initiated: 2011-12-21
Posted: 2012-01-13
Terminated: 2012-05-10
Recalling firm: Integra Pain Management
Product: Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Integra sent an Urgent: Medical Device Correction Notice letter dated December 21, 2011 to all affected customers. The letter identified the product, problem and actions to be taken. Integra is requesting that customers further distribute the communications along with the package insert to all appropriate health care practitioners at their facility. The letter instructs customers to complete and return the attached acknowledgement form by fax to 609-750-7999. For questions or concerns call 609-750-2814.
Quantity in commerce: 24690 units
Distribution: (USA) Nationwide Distribution
Product codes and lots: W1001285, W1001313, W1002070, W1003048, W1003050, W1003228, W1004005, W1004275, W1004090, W1005002,, W1006124, W1005003, W1006125, W1007156, W1007157, W1007160, W1007161, W1008142, W1008143, W1008144, W1008145, W1009295, W1010034, W1010035, W1010085, W1010086, W1012248, W1012249, W1012250, W1101101, W1101102, W1101103, W1102113, W1102114, W1103150, W1103193, W1103192, W1103194, W1105094, W1105095, W1105096, W1108087, W1108190, W1108192, W1108191, W1108193, W1108194, W1109005, W1109006, W1109007, W1110170.

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)