Class II — IMPLANTCAST GMBH
| Recalling firm | implantcast GmbH |
|---|---|
| Registered facility | implantcast GmbH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor. |
| Product | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cove… |
| Quantity | 41 units (U.S.) |
| Distribution | U.S. Nationwide distribution in the states of FL and TX. |
| Initiated | 2021-05-10 |
| Classified | 2021-07-09 |
| Terminated | 2022-11-18 |
| Recall number | Z-2050-2021 |
| 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-2050-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88047/
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