Z-0225-2015 Class II Terminated
FDA device recall Z-0225-2015 was initiated by Medacta Usa on October 21, 2014 and is designated Class II. 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. The recall status is terminated (terminated March 14, 2016). Affected quantity: 32 oblique handles.
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