Drug recall
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
FDA recall event 73856 · Class II · Stanmore Implants Worldwide Ltd.
Key facts
| Event ID | 73856 |
|---|---|
| Recall numbers | Z-1623-2016 |
| Recalling firm | Stanmore Implants Worldwide Ltd. |
| Product type | Devices |
| Products | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect component used to manufacture distal femoral replacement. |
| Initiation date | Apr 12, 2016 |
| Report date | May 18, 2016 |
| Termination date | Jan 26, 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: