Z-0606-2010

Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx...

Name: Z-0606-2010 Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2009-12-07
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2009-12-07 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY"... on 2009-12-07. The reason FDA records is "The Trocar may not fully engage with the Rod Inserter or may prematurely disengage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0606-2010
Status: Terminated
Initiated: 2009-12-07
Posted: 2010-01-12
Terminated: 2011-01-14
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
Root cause tag: design
FDA root cause: Device Design
Action: On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.
Quantity in commerce: 199 units
Distribution: Nationwide distribution, and the Netherlands
Product codes and lots: All Codes

Product code LXH

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