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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 Device Recall KyphX Osteo Introducer Systemsee related information
Date Initiated by FirmJune 23, 2008
Date PostedSeptember 18, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall NumberZ-2347-2008
Recall Event ID 48988
Product Classification Orthopedic manual surgical instrument. - Product Code LXH
ProductKyphX 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
ActionRecall 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 Commerce310 units
DistributionClass II Recall - Nationwide Distribution.
Total Product Life CycleTPLC Device Report
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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