Z-0046-2012

Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used...

Name: Z-0046-2012 Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used...
Creator: Interventional Spine Inc
Published: 2011-02-03
License: https://open.fda.gov/license/

Interventional Spine, Inc. / initiated 2011-02-03 / Terminated / root cause: manufacturing process

FDA source

Interventional Spine Inc began a recall of 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... on 2011-02-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0046-2012
Status: Terminated
Initiated: 2011-02-03
Posted: 2011-10-13
Terminated: 2013-02-05
Recalling firm: Interventional Spine, Inc.
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.
Product code: HXX Screwdriver
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
Root cause tag: manufacturing process
FDA root 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: 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.
Product codes and lots: 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

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)