Class 2 Device Recall PERPOS Driver

• Date Initiated by Firm: February 03, 2011
• Date Posted: October 13, 2011
• Recall Status: Terminated on February 05, 2013
• Recall Number: Z-0047-2012
• Recall Event ID: 58461
• Product Classification: Orthopedic Screwdriver - Product Code HXX
• Product: PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.
• Code Information: DRIVER CATALOG NO. 6112; 050507A, 061509A, 071808A, 112507A, 042709E
• 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: This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure
• FDA Determined Cause: Nonconforming Material/Component
• Action: Interventional Spine, Inc. sent an "Urgent Recall" letter dated March 15, 2011 to all affected customers. The letter included; affected product, reason for recall and recommendations. Customers were asked to immediately examine inventory, quarantine affected product and to notify International Spine, Inc if any product remain. For information on this recall contact the firm at (949) 472-0006.
• Quantity in Commerce: 12 units
• Distribution: Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.
• 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.