Medical device recalls Moderate risk

Smith & Nephew Orthopaedics GmbH recalls INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

Recall date
April 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1133-2022
FDA classification
Class II
Brand / firm
Smith & Nephew Orthopaedics GmbH
Sold / distributed
Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.

Why it was recalled

Right nails were anodized, marked, and labelled as left nails and vice versa

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

What was recalled

INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

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