Class II — IMPLANTCAST GMBH
| Recalling firm | implantcast GmbH |
|---|---|
| Registered facility | implantcast GmbH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted. |
| Product | 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 Size 46/52 mm REF number 02424652 |
| Quantity | 304, 3 in US |
| Distribution | Distribution in Europe and US states of Texas, Rhode Island and Georgia. |
| Initiated | 2017-12-28 |
| Classified | 2018-07-20 |
| Terminated | 2020-09-01 |
| Recall number | Z-2517-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IMPLANTCAST GMBH (Z-2517-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80498/
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