Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

Recall date
October 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0097-2018
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Why it was recalled

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

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

What was recalled

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

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