FDA Medical Device Recalls (openFDA)
Medacta Usa: The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
- Recall number
- Z-0225-2015
- Recalling firm
- Medacta Usa
- Product
- The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
- Status
- Terminated
- Initiated
- 2014-10-21
- Posted
- 2014-11-18
- Terminated
- 2016-03-14
- 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.
- Lot, serial or model codes
- Model Number: 03.22.10.0262; Lot Number: 1314256
- 510(k) numbers
- ["K110927"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3015500078
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28