PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used ov

FDA device recall Z-0419-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Interventional Spine Inc

Reason for recall

The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.

Action taken

The recall communication was initiated on February 22, 2008 with Interventional Spine forwarding an Urgent Recall Notification to all their customers (via email). The notification informed the customers of the problem identified and instructions for the recall. If you have any questions, contact the Vice President, Quality, Regulatory and Clinical Affairs at (949) 525-1493 or email: jmetcalf@i-spineinc.com.

Root cause

Pending

Status

Terminated

Product code

HTW

Quantity affected

4

Distribution

Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.

Date initiated

2008-02-22

Date posted

2012-01-11

Date terminated

2012-02-29

Location

Irvine, CA