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U.S. Department of Health and Human Services

Class 2 Device Recall Single Use PERPOS PLS System

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  Class 2 Device Recall Single Use PERPOS PLS System see related information
Date Initiated by Firm February 22, 2008
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0420-2012
Recall Event ID 60096
Product Classification Bit, drill - Product Code HTW
Product Single Use PERPOS PLS System, Catalog #9045-01

Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints.
Code Information Lot#090907A
Recalling Firm/
Manufacturer		 Interventional Spine Inc
13700 Alton Pkwy Ste 160
Irvine CA 92618-1618
For Additional Information Contact
949-472-0006
Manufacturer 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.
FDA Determined
Cause 2		 Pending
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: jmetcalf@i-spineinc.com.
Quantity in Commerce 65
Distribution Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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