Z-1057-2015Class II

KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R...

Name: Z-1057-2015 KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2015-01-13
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2015-01-13 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices on 2015-01-13. FDA classified it as Class II and gives the reason as "The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments". 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-1057-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-02-05
Terminated: 2015-07-13
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Product code: LYQ Accessories, Fixation, Spinal Intervertebral Body
Reason for recall: The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.
Quantity in commerce: 239 units
Distribution: Nationwide and Canada
Product codes and lots: WI14H054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-05

Product code LYQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)