Z-0074-2008

Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets...

Name: Z-0074-2008 Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2007-08-24
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2007-08-24 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System... on 2007-08-24. The reason FDA records is "Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws". 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-0074-2008
Status: Terminated
Initiated: 2007-08-24
Posted: 2007-12-13
Terminated: 2009-08-21
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA, The Netherlands, Australia, and Canada.
Product codes and lots: Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.

Product code KWP

K052144Class IITsrh Spinal SystemMedtronic Sofamor Danek / cleared 2005-08-31

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)