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

Date posted by the FDA

Aug. 6, 2005

Status

Terminated

Filed by

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.

Reason

The product is labeled as sterile, but this lot was not sterilized.

Distribution pattern

United States and Canada.

Quantity

140

Codes and lots

Lot W05C5509.

Recall started

May 27, 2005

Device type

Intervertebral Fusion Device With Bone Graft, Lumbar

Root cause (FDA)

Other

Recall number

Z-1090-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1090-05. The agency record governs; check it and the company before acting.