Medical device recalls Moderate risk

Medicrea International recalls Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Recall date
September 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0827-2020
FDA classification
Class II
Brand / firm
Medicrea International
Sold / distributed
Nationwide

Why it was recalled

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

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 Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

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