FDA Medical Device Recalls (openFDA)
Interventional Spine Inc: 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.
- Recall number
- Z-0046-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-02-03
- Posted
- 2011-10-13
- Terminated
- 2013-02-05
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 3003523239
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28