InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, L

FDA device recall Z-1033-2009 · posted 2009-03-05 · Terminated

Recall details

Recalling firm

Intelifuse Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

HTW

Quantity affected

2149 units

Distribution

Nationwide Distribution - NY and NJ.

Date initiated

2008-07-30

Date posted

2009-03-05

Date terminated

2011-06-22

Location

New Orleans, LA