The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
FDA device recall Z-0225-2015 · posted 2014-11-18 · Terminated
Recall details
- Recalling firm
- Medacta Usa
- Reason for recall
- The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 32 oblique handles
- Distribution
- Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
- Date initiated
- 2014-10-21
- Date posted
- 2014-11-18
- Date terminated
- 2016-03-14
- Location
- Chicago, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MECTALIF (K110927) | Medacta International | 2011-06-13 |