FDA Device recall Z-1219-2015
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ceme…
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ceme… by Zimmer, citing PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1219-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-05 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | TX |
Product
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Reason
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Identifiers
| code_info | Item No. 00-5852-052-10; Lot 62866438 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2015%22
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