Medical device recalls Moderate risk

Brasseler USA, Medical L.L.C. recalls Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

Recall date
January 28, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0707-2022
FDA classification
Class II
Brand / firm
Brasseler USA, Medical L.L.C.
Sold / distributed
US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.

Why it was recalled

One lot of product was distributed in unsealed packaging

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

What was recalled

Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S

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