Class 2 Device Recall Integra

• Date Initiated by Firm: December 21, 2011
• Date Posted: January 13, 2012
• Recall Status: Terminated on May 10, 2012
• Recall Number: Z-0751-2012
• Recall Event ID: 60798
• 510(K)Number: K961113
• Product Classification: Drills, burrs, trephines & accessories (manual) - Product Code HBG
• Product: Cranial Access Kit Ref HITHSP04 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.
• Code Information: W1006237, W1010078, W1103184, W1104167, W1108229.
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management; 3498 West 2400 South #1050; Salt Lake City UT 84119
• For Additional Information Contact: 801-886-9505
• 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: 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: 210 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