EcoFit cup cementless: Model — Class II medical device recall Z-2050-2021
Terminated recall by IMPLANTCAST GMBH, reported 2021-07-21, distributed nationwide. A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, whic
| Recall number | Z-2050-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMPLANTCAST GMBH, Buxtehude, Germany |
| Recall initiated | 2021-05-10 |
| Classified | 2021-07-09 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2022-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 41 units |
| UPC / GTIN / UDI-DI | 04048844005368, 04048844005375, 04048844005382, 04048844005399, 04048844005405, 04048844005412, 04048844005429, 04048844005436, 04048844005443, 04048844005450, 04048844005467, 04048844005474 |
| Lot numbers | 02200048, 02200050, 02200052, 02200054, 02200056, 02200058, 02200060, 02200062, 02200064, 02200066, 02200068, 1416I6G089, 1439O4K008, 15190KC048, 1736252001, 1736252003, 1736252004, 1736252006, 1736252007, 1736252008, 1736252010, 1736253002, 1736253004, 1736253005, 1736253006, 1736253007, 1736253008, 1736253014, 1736253015, 1736253016, 1736253017, 1736253019, 1736253020, 1736253021, 1736253022, 1736253023, 1738104009, 173810D001, 173810D002, 173810D003 and 197 more |
| Model numbers | 02200046 |
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 cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2050-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.