Z-0225-2015Class II

The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage...

Name: Z-0225-2015 The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage...
Creator: Medacta Usa
Published: 2014-10-21
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2014-10-21 / Terminated / root cause: manufacturing process

FDA source

Medacta Usa began a recall of The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants on 2014-10-21. FDA classified it as Class II and gives the reason as "The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0225-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-21
Posted: 2014-11-18
Terminated: 2016-03-14
Recalling firm: Medacta USA, Inc.
Product: The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 32 oblique handles
Distribution: Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
Product codes and lots: Model Number: 03.22.10.0262; Lot Number: 1314256

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0225-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0225-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-18

Product code MAX

K110927Class IIMectalifMedacta International / cleared 2011-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)