MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

FDA Recall #Z-1404-2023 — Class II — March 8, 2023

Recall #Z-1404-2023 Date: March 8, 2023 Classification: Class II Status: Completed

Product Description

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

Reason for Recall

There is a potential for breakage of the small screw used to affix the anti-backout plate.

Recalling Firm

Medacta Usa Inc — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

17 unis

Distribution

US: ID, TX, GA, VA, AZ

Code Information

UDI/DI 07630345732323, All Lot Numbers

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated