Kyphon Inc 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Kyphon Inc
Lot Codes / Batch Numbers
Lot code J8052810
Products Sold
Lot code J8052810
Kyphon Inc is recalling KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, F due to Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026