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U.S. Department of Health and Human Services

Class 2 Device Recall KyphX Osteo Introducer System

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 Class 2 Recall
KyphX Osteo Introducer System
see related information
Date Posted September 18, 2008
Recall Status1 Terminated 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, California 94089-1103
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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