Drug recall
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm…
FDA recall event 80498 · Class II · IMPLANTCAST GMBH
Key facts
| Event ID | 80498 |
|---|---|
| Recall numbers | Z-2517-2018 |
| Recalling firm | IMPLANTCAST GMBH |
| Product type | Devices |
| Products | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. |
| Initiation date | Dec 28, 2017 |
| Report date | Aug 1, 2018 |
| Termination date | Sep 1, 2020 |
| City | Buxtehude |
| Country | Germany |
| FEI number | 3012523063 |
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: