FDA-Device2015-03-11Class II

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

Zimmer, Inc.
Hazard

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

Sold states
US Distribution to the state of TX
Affected count
1 unit
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2015

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