KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3
FDA device recall Z-2347-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Kyphon Inc
- 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.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 310 units
- Distribution
- Class II Recall - Nationwide Distribution.
- Date initiated
- 2008-06-23
- Date posted
- 2008-09-18
- Date terminated
- 2009-10-07
- Location
- Sunnyvale, CA
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