Z-1032-2009

InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New...

Name: Z-1032-2009 InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New...
Creator: Intelifuse Inc
Published: 2008-07-30
License: https://open.fda.gov/license/

Intelifuse, Inc. / initiated 2008-07-30 / Terminated / root cause: manufacturing process

FDA source

Intelifuse Inc began a recall of 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... on 2008-07-30. The reason FDA records is "Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1032-2009
Status: Terminated
Initiated: 2008-07-30
Posted: 2009-03-05
Terminated: 2011-06-22
Recalling firm: Intelifuse, Inc.
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.
Product code: HTW Bit, Drill
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Nos.: 984266, 78993, N64730, 17262-01, 064798, and 82030.

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)