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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm December 21, 2011
Date Posted January 13, 2012
Recall Status1 Terminated 3 on May 10, 2012
Recall Number Z-0758-2012
Recall Event ID 60798
510(K)Number K961113  
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
Product 1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119.

Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.
Code Information 167436, 168617, 170048, 171235, 172209, 172961, 174616, 175111, 175719, 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079.
Recalling Firm/
Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City UT 84119
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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 2,305 units
Distribution (USA) Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBG and Original Applicant = CLINICAL NEURO SYSTEMS LLC.