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U.S. Department of Health and Human Services

Class 2 Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System

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  Class 2 Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System see related information
Date Initiated by Firm March 23, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-3175-2011
Recall Event ID 58425
510(K)Number K041454  K011811  
Product Classification Arthroscope - Product Code HRX
Product Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA

Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
Code Information Lot Number: 0001653390
Recalling Firm/
Manufacturer		 Medtronic Spine LLC (formerly Kyphon Inc.)
1221 Crossman Ave
Sunnyvale CA 94089-1103
For Additional Information Contact Michael Armstrong
408-548-6740
Manufacturer Reason
for Recall		 Device was shipped past the labeled expiration date.
FDA Determined
Cause 2		 Employee error
Action On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.
Quantity in Commerce 44
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = KYPHON, INC.
510(K)s with Product Code = HRX and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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