Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Recall date
May 4, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2163-2018
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
International only: United Arab Emirates, Spain, Mexico

Why it was recalled

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

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 GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

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