Medical device recalls Moderate risk

Stanmore Implants Worldwide Ltd. recalls Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Recall date
April 12, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1623-2016
FDA classification
Class II
Brand / firm
Stanmore Implants Worldwide Ltd.
Sold / distributed
US distribution to OH.

Why it was recalled

Incorrect component used to manufacture distal femoral replacement.

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

What was recalled

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

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