Z-1405-2023 Class II
FDA device recall Z-1405-2023 was initiated by Medacta Usa Inc on March 8, 2023 and is designated Class II. Reason for recall: There is a potential for breakage of the small screw used to affix the anti-backout plate. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Reason for Recall
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Distribution Pattern
US: ID, TX, GA, VA, AZ
Code Information
UDI/DI 07630345732330, All Lot Numbers