Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral…

Recall date
September 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0200-2019
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US Distribution to the states of: KS and TN.

Why it was recalled

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

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 Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

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