Medical device recalls Moderate risk

Zimmer, Inc. recalls Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/C…

Recall date
February 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1219-2015
FDA classification
Class II
Brand / firm
Zimmer, Inc.
Sold / distributed
US Distribution to the state of TX

Why it was recalled

PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

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

What was recalled

Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.

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