Z-2347-2008

KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First...

Name: Z-2347-2008 KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First...
Creator: Kyphon Inc
Published: 2008-06-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-06-23 / Terminated / root cause: design

FDA source

Kyphon Inc began a recall of KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502... on 2008-06-23. The reason FDA records is "Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2347-2008
Status: Terminated
Initiated: 2008-06-23
Posted: 2008-09-18
Terminated: 2009-10-07
Recalling firm: Medtronic, Inc.
Product: KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient.
Root cause tag: design
FDA root cause: Mixed-up of materials/components
Action: Recall initiated on June 23, 2008. A recall letter and reconciliation form was sent out via e-mail to sales representatives for hand delivery to US hospital consignees. The consignees were asked to review the letter and complete/return the reconciliation form to the firm. If you have any questions contact Kyphon, Inc. at 1-408-548-6740.
Quantity in commerce: 310 units
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: Lot code J8052810

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)