Drug recall
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers…
FDA recall event 94923 · Class II · Zimmer, Inc.
Key facts
| Event ID | 94923 |
|---|---|
| Recall numbers | Z-2450-2024 |
| Recalling firm | Zimmer, Inc. |
| Product type | Devices |
| Products | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| Initiation date | Jul 2, 2024 |
| Report date | Aug 7, 2024 |
| 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: