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U.S. Department of Health and Human Services

Class 2 Device Recall Reusable BONELOK PLS System;

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  Class 2 Device Recall Reusable BONELOK PLS System; 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-0046-2012
Recall Event ID 58461
Product Classification Orthopedic Screwdriver - Product Code HXX
Product Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02.
Interventional Spine, Inc.

A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe.
Code Information CATALOG #'s: 9039-01LOT NUMBERS: 092707-01, 102907, 102907-02 thru -03, 120107-01 thru -10, 050208-21 thru -30, 050208-15 thru -16, 050108-01, 041708-01, 050208-11 thru -20, 060208-01 thru -10, 050208-41 thru -47  CATALOG #'s: 9039-02 LOT NUMBERS: 050208-11 thru -20, 050108-11
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 60 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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