Drug recall
METS SMILES Total Knee Replacement
FDA recall event 74403 · Class II · Stanmore Implants Worldwide Ltd.
Key facts
| Event ID | 74403 |
|---|---|
| Recall numbers | Z-2553-2016 |
| Recalling firm | Stanmore Implants Worldwide Ltd. |
| Product type | Devices |
| Products | METS SMILES Total Knee Replacement |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to… |
| Initiation date | May 31, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Mar 2, 2017 |
| City | Borehamwood |
| Country | United Kingdom |
| FEI number | 3004105610 |
At a glance
- 1–9 Products in this recall
- None 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: