Drug recall
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular…
FDA recall event 78109 · Class II · Limacorporate S.p.A
Key facts
| Event ID | 78109 |
|---|---|
| Recall numbers | Z-0068-2018 |
| Recalling firm | Limacorporate S.p.A |
| Product type | Devices |
| Products | Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and… |
| Initiation date | Sep 8, 2017 |
| Report date | Nov 15, 2017 |
| City | San Daniele del Friuli |
| Country | Italy |
| FEI number | 3008021110 |
At a glance
- 1–9 Products in this recall
- 1–9 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: