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.
FDA Recall Z-0046-2012 · Posted 2011-10-13
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Recalling FirmInterventional Spine Inc
Recall StatusTerminated
Product CodeHXX
Date Initiated2011-02-03
Date Terminated2013-02-05
Product Quantity60 units
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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