PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.
FDA Recall Z-0419-2012 · Posted 2012-01-11
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Recalling FirmInterventional Spine Inc
Recall StatusTerminated
Product CodeHTW
Date Initiated2008-02-22
Date Terminated2012-02-29
Product Quantity4
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.
Firm Action
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: [email protected].
Root Cause
Pending
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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