Recall Z-0225-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medacta Usa
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
| Date | Nov 18, 2014 (initiated Oct 21, 2014) |
| Status | Terminated |
| Reason | The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery. |
| Root cause | Employee error |
| Action | Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided. Customers with questions can contact Medacta USA at 805-910-6511. |
| Quantity | 32 oblique handles |
| Distribution | Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110927 | MECTALIF Medacta International, Jun 13, 2011 |