Z-0225-2015 Class II Terminated

Recalled by Medacta Usa — Chicago, IL

Recall Details

Product Type
Devices
Report Date
November 26, 2014
Initiation Date
October 21, 2014
Termination Date
March 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 oblique handles

Product Description

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

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.

Distribution Pattern

Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.

Code Information

Model Number: 03.22.10.0262; Lot Number: 1314256