Recall Z-1090-05 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Warsaw Orthopedic, Inc.
Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
| Date | Aug 6, 2005 (initiated May 27, 2005) |
| Status | Terminated |
| Reason | The product is labeled as sterile, but this lot was not sterilized. |
| Root cause | Other |
| Quantity | 140 |
| Distribution | United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.