Drug recall
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip…
FDA recall event 70500 · Class II · Zimmer, Inc.
Key facts
| Event ID | 70500 |
|---|---|
| Recall numbers | Z-1219-2015 |
| Recalling firm | Zimmer, Inc. |
| Product type | Devices |
| Products | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. |
| Initiation date | Feb 5, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | Sep 23, 2015 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1000220733 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: