InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.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.

Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.

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.