Z-3175-2011

Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number...

Name: Z-3175-2011 Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number...
Creator: Medtronic Spine LLC (formerly Kyphon Inc.)
Published: 2011-03-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-03-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Spine LLC (formerly Kyphon Inc.) began a recall of Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by... on 2011-03-23. The reason FDA records is "Device was shipped past the labeled expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3175-2011
Status: Terminated
Initiated: 2011-03-23
Posted: 2011-09-09
Terminated: 2011-09-09
Recalling firm: Medtronic, Inc.
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.
Product code: HRX Arthroscope
Reason for recall: Device was shipped past the labeled expiration date.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot Number: 0001653390

Product code HRX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)