Z-0420-2012

Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile...

Name: Z-0420-2012 Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile...
Creator: Interventional Spine Inc
Published: 2008-02-22
License: https://open.fda.gov/license/

Interventional Spine, Inc. / initiated 2008-02-22 / Terminated / root cause: supplier

FDA source

Interventional Spine Inc began a recall of Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components... on 2008-02-22. The reason FDA records is "The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0420-2012
Status: Terminated
Initiated: 2008-02-22
Posted: 2012-01-11
Terminated: 2012-02-29
Recalling firm: Interventional Spine, Inc.
Product: Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints.
Product code: HTW Bit, Drill
Reason for recall: The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use.
Root cause tag: supplier
FDA root cause: Pending
Action: The recall communication was initiated on February 22, 2008 with Interventional Spine forwarding an Urgent Recall Notification to all their customers (via email). The notification informed the customers of the problem identified and instructions for the recall. If you have any questions, contact the Vice President, Quality, Regulatory and Clinical Affairs at (949) 525-1493 or email: [email protected].
Quantity in commerce: 65
Distribution: Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe.
Product codes and lots: Lot#090907A

Product code HTW

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)