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U.S. Department of Health and Human Services

Class 2 Device Recall CNS INTERCHANGEABLE BIT CRANIAL DRILL

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  Class 2 Device Recall CNS INTERCHANGEABLE BIT CRANIAL DRILL see related information
Date Initiated by Firm July 13, 2009
Date Posted September 21, 2009
Recall Status1 Terminated 3 on October 23, 2009
Recall Number Z-2084-2009
Recall Event ID 52683
510(K)Number K961113  
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
Product Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeSciences Corporation, Salt Lake City, Utah 84104.

Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
Code Information Lot number W0905239
Recalling Firm/
Manufacturer		 Integra Life Sciences Corporation
3395 W 1820 S
Salt Lake City UT 84104-4921
For Additional Information Contact
801-886-9505
Manufacturer Reason
for Recall		 Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.
Quantity in Commerce 44 units
Distribution Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
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.
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