Z-1090-05

Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog...

Name: Z-1090-05 Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog...
Creator: Warsaw Orthopedic, Inc.
Published: 2005-05-27
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2005-05-27 / Terminated / root cause: labeling and UDI

FDA source

Warsaw Orthopedic, Inc. began a recall of Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423 on 2005-05-27. The reason FDA records is "The product is labeled as sterile, but this lot was not sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1090-05
Status: Terminated
Initiated: 2005-05-27
Posted: 2005-08-06
Terminated: 2005-09-20
Recalling firm: Warsaw Orthopedic, Inc.
Product: Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The product is labeled as sterile, but this lot was not sterilized.
Root cause tag: labeling and UDI
FDA root cause: Other
Quantity in commerce: 140
Distribution: United States and Canada.
Product codes and lots: Lot W05C5509.

Product code MAX

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)