Class 2 Device Recall PERPOS PLS SYSTEM

• Date Initiated by Firm: March 23, 2011
• Date Posted: July 01, 2011
• Recall Status: Terminated on February 14, 2013
• Recall Number: Z-2718-2011
• Recall Event ID: 58465
• Product Classification: Passer, wire, orthopedic - Product Code HXI
• Product: PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
• Code Information: LOT #'s: 040309-A, 041409-A
• 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 K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw
• FDA Determined Cause: Pending
• Action: Interventional Spine sent an RECALL NOTIFICATION letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to take the following actions: Immediately examine inventory and quarantine product subject to recall. In addition, if this product was further distributed, please notify the Vice President Quality Assurance at once. Consignee were asked to also complete and return the enclosed response form as soon as possible. Consignee with questions were directed to the Consignees' Regional Director or the Vice President Quality Assurance. For further questions, please call (949) 472-0006
• Quantity in Commerce: 864 units total for all products
• Distribution: Nationwide Distribution including the states of to NC, NY, TN & VA
• 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.