FDA Device recall Z-2050-2021
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover
- FDA Device
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover by Implantcast, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2050-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-10 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Implantcast |
| Distribution | US |
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
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.
Identifiers
| code_info | Instructions for Use Reference Number: ECOCUOPU and Surgical Technique Reference Number:09300038US Model(Catalog Num…Instructions for Use Reference Number: ECOCUOPU and Surgical Technique Reference Number:09300038US Model(Catalog Number)/Description: 02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover; UDI: 04048844005368 Lot Numbers: 1736252001; 1736252003; 1736252004; 1736252006; 1736252007; 1736252008; 1736252010; 18481C0027; 18481C0010; 18481C0004; 18481C0013; 18481C0005; 18481C0024; 02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover; UDI: 04048844005375 Lot Numbers: 17420NM001 17420NM002 17420NM003 17420NM005 17420NM007 17420NM010 17420NM011 17420NM012 17420NM013 17420NM014 17420NM015 17420NM016 17420NM018 17420NM019 17420NM020 17420NM021 17420NM022 17420NM023 17420NM025 17420NM026 02200050 /EcoFit¿ cup cementless ¿ 50mm incl. central hole cover; UDI: 04048844005382 Lot Numbers: 174111N008 174111N012 174111N018 190414M002 190414M003 190414M004 190414M012 190414N016 174111N002 174111N005 174111N006 174111N013 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.