Recall Z-1037-2012 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Orthofix, Inc.
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
| Date | Feb 15, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment. |
| Root cause | Device Design |
| Action | Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals. |
| Quantity | 52 |
| Distribution | Nationwide and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103111 | FORZA SPACER SYSTEM Orthofix, Inc., Mar 23, 2011 |