Medical device recalls Moderate risk

Medicrea International recalls Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Recall date
October 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1156-2020
FDA classification
Class II
Brand / firm
Medicrea International
Sold / distributed
OH, VA

Why it was recalled

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

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

What was recalled

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

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