Medical device recalls Moderate risk

Medacta Usa Inc recalls MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

Recall date
March 8, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1401-2023
FDA classification
Class II
Brand / firm
Medacta Usa Inc
Sold / distributed
US: ID, TX, GA, VA, AZ

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

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