Intelifuse Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Intelifuse Inc
Lot Codes / Batch Numbers
Lot Nos.: 984267, 78994, N64731, 17262-02, 064799, and 82031.
Products Sold
Lot Nos.: 984267, 78994, N64731, 17262-02, 064799, and 82031.
Intelifuse Inc is recalling InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste due to Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shav. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026