Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Recall date
July 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3172-2024
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US, Canada, Norway

Why it was recalled

Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.

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

What was recalled

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

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