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U.S. Department of Health and Human Services

Class 2 Device Recall InteliFUSE, Drill Bit, 1.50 mm, JLatch

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  Class 2 Device Recall InteliFUSE, Drill Bit, 1.50 mm, JLatch see related information
Date Initiated by Firm July 30, 2008
Date Posted March 05, 2009
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-1032-2009
Recall Event ID 49372
Product Classification Drill Bit - Product Code HTW
Product InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom

Intended Use: Creating of holes for implant placement.
Code Information Lot Nos.: 984266, 78993, N64730, 17262-01, 064798, and 82030. 
Recalling Firm/
Manufacturer		 Intelifuse Inc
1515 Poydras Street
Suite 1490
New Orleans LA 70112
For Additional Information Contact Megan Ohar
504-561-1100
Manufacturer Reason
for Recall		 Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
FDA Determined
Cause 2		 Process control
Action The firm initiated their recall on July 31, 2008 via telephone and Urgent Recall Notice to their current distributor, Integra. The letter asked them to complete, sign, and return the enclosed Recall Acknowledgment and Return Form. The letter also stated that InteliFUSE would travel to their designated Distribution Center(s) to ensure testing and replacement of all defective units once the form has been received. The firm sent follow-up Urgent Recall Notice letters on August 14, 2008 directing the distributor to recall from the hospitals to whom they distributed the product and to two hospitals which were shipped the products directly. The letter asked that use of the affected products be immediately ceased and that the any stock on hand be quarantined. The Recall Acknowledgment and Return Form should be completed, signed, and returned and the products should be returned to InteliFUSE for immediate replacement.
Quantity in Commerce 2133 units
Distribution Nationwide Distribution - NY and NJ.
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.
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