Medical device recalls Moderate risk

DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Recall date
July 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2949-2018
FDA classification
Class II
Brand / firm
DePuy Orthopaedics, Inc.
Sold / distributed
The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

Why it was recalled

This unit may be missing the screw/collet Assembly

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

What was recalled

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

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