Date Initiated by Firm |
June 23, 2008 |
Date Posted |
September 18, 2008 |
Recall Status1 |
Terminated 3 on October 07, 2009 |
Recall Number |
Z-2347-2008 |
Recall Event ID |
48988 |
Product Classification |
Orthopedic manual surgical instrument. - Product Code LXH
|
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). |
Code Information |
Lot code J8052810 |
Recalling Firm/ Manufacturer |
Kyphon Inc 1221 Crossman Ave Sunnyvale CA 94089-1103
|
For Additional Information Contact |
408-548-6740
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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