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U.S. Department of Health and Human Services

Class 2 Device Recall PERPOS Driver

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  Class 2 Device Recall PERPOS Driver see related information
Date Initiated by Firm February 03, 2011
Date Posted October 13, 2011
Recall Status1 Terminated 3 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 2		 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.
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