Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer Systemsee related information
Date Initiated by FirmMarch 23, 2011
Date PostedSeptember 09, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall NumberZ-3175-2011
Recall Event ID 58425
510(K)NumberK011811 K041454 
Product Classification Arthroscope - Product Code HRX
ProductKyphon 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 ContactMichael Armstrong
408-548-6740
Manufacturer Reason
for Recall		Device was shipped past the labeled expiration date.
FDA Determined
Cause 2		Employee error
ActionOn 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 Commerce44
DistributionNationwide 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.
510(K) Database510(K)s with Product Code = HRX
510(K)s with Product Code = HRX
-
-