IMPLANTCAST GMBH Recall 88047
Description: EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover; 02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover; 02200050 /EcoFit¿ cup cementless ¿ 50mm incl. central hole cover; 02200052 /EcoFit¿ cup cementless ¿ 52mm incl. central hole cover; 02200054 /EcoFit¿ cup cementless ¿ 54mm incl. central hole cover; 02200056 /EcoFit¿ cup cementless ¿ 56mm incl. central hole cover; 02200058 /EcoFit¿ cup cementless ¿ 58mm incl. central hole cover; 02200060 /EcoFit¿ cup cementless ¿ 60mm incl. central hole cover; 02200062 /EcoFit¿ cup cementless ¿ 62mm incl. central hole cover; 02200064 /EcoFit¿ cup cementless ¿ 64mm incl. central hole cover; 02200066 /EcoFit¿ cup cementless ¿ 66mm incl. central hole cover; 02200068 /EcoFit¿ cup cementless ¿ 68mm incl. central hole cover;
IMPLANTCAST GMBH Recall 88047 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2050-2021 |
| Event ID | 88047 |
| Event Description | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover; 02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover; 02200050 /EcoFit¿ cup cementless ¿ 50mm incl. central hole cover; 02200052 /EcoFit¿ cup cementless ¿ 52mm incl. central hole cover; 02200054 /EcoFit¿ cup cementless ¿ 54mm incl. central hole cover; 02200056 /EcoFit¿ cup cementless ¿ 56mm incl. central hole cover; 02200058 /EcoFit¿ cup cementless ¿ 58mm incl. central hole cover; 02200060 /EcoFit¿ cup cementless ¿ 60mm incl. central hole cover; 02200062 /EcoFit¿ cup cementless ¿ 62mm incl. central hole cover; 02200064 /EcoFit¿ cup cementless ¿ 64mm incl. central hole cover; 02200066 /EcoFit¿ cup cementless ¿ 66mm incl. central hole cover; 02200068 /EcoFit¿ cup cementless ¿ 68mm incl. central hole cover; |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of FL and TX. |
| Quantity | 41 units (U.S.) |
| Recall 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. |
| Device Classification | 20210721 |
| Device Code Info | 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 174111N022 174111N023 174111N026 190625J027 190625J026 190625J028 190625J009 190625J012 190625J014 190625J021 190625J020 190625J001 190625J017 190625J006 190625J002 190625J004 190625J018 02200052 /EcoFit¿ cup cementless ¿ 52mm incl. central hole cover; UDI: 04048844005399 Lot Numbers: 1736253002 1736253005 1736253007 1736253008 1736253015 1736253016 1736253017 1736253021 1736253004 1736253006 1736253014 1736253019 1736253020 1736253022 1736253023 190909E021 190909E005 190909E014 190909E004 190909E017 190909E025 190909E002 190909E018 190909E023 190909E006 190909E009 190909E001 02200054 /EcoFit¿ cup cementless ¿ 54mm incl. central hole cover; UDI: 04048844005405 Lot Numbers: 1748194005 1748194007 1748194008 1748194011 1748194013 1748194016 1748194022 1748194023 1748194025 1748194026 1748194001 1748194003 1748194006 1748194012 1748194017 1748194018 1748194020 1748194028 1849208014 1849208004 1849208012 185019I006 1849208001 1849208006 185019I004 1849208009 02200056 /EcoFit¿ cup cementless ¿ 56mm incl. central hole cover; UDI: 04048844005412 Lot Numbers: 174817C002 174817C004 174817C009 174817C010 174817C011 174817C013 17481M2002 17481M2007 174817C001 174817C003 174817C005 174817C007 174817C008 174817C012 17481L7001 17481M2005 17481M2008 17481M2011 19061JB024 19061JB008 19061JB005 19061JB003 19061JB020 19061JB006 19061JB023 19061JB002 19061JB019 02200058 /EcoFit¿ cup cementless ¿ 58mm incl. central hole cover; UDI: 04048844005429 Lot Numbers: 1738104009 173810D001 173810D002 173810D003 173810D004 173810D006 173810D007 173810D008 173810D009 173810D012 173810D014 173810D015 173810D005 173810D010 173810D011 173810D013 02200060 /EcoFit¿ cup cementless ¿ 60mm incl. central hole cover; UDI: 04048844005436 Lot Numbers: 1738116001 1738116002 1738116003 1738116004 1738116005 1738116006 1738116008 1738116018 1738116019 1738116021 1738116023 1738116025 1738116007 1738116010 1738116013 02200062 /EcoFit¿ cup cementless ¿ 62mm incl. central hole cover; UDI: 04048844005443 Lot Numbers: 1741126001 1741126003 1741126004 1741126005 1741126010 1741126011 1741126012 1741126015 1741126017 1741126020 15190KC048 1741126013 1741126016 1741126006 02200064 /EcoFit¿ cup cementless ¿ 64mm incl. central hole cover; UDI:04048844005450 Lot Numbers: 1741104001 1741104002 1741104003 1741104005 1741104007 1741104018 1741104020 1741104021 1741104022 1741104010 1741104004 1741104019 02200066 /EcoFit¿ cup cementless ¿ 66mm incl. central hole cover; UDI: 04048844005467 Lot Numbers: 174110E002 174110E004 174110E007 174110E008 174110E009 174110E011 174110E013 174110E003 174110E012 174110E010 174110E006 174110E005 02200068 /EcoFit¿ cup cementless ¿ 68mm incl. central hole cover; UDI: 04048844005474 Lot Numbers: 17410JK001 17410JK002 17410JK003 17410JK004 17410KM001 17410KM003 17410KM004 17410KM005 17410KM006 17410KM007 17410KM009 17410KM010 17410KM011 1416I6G089 1439O4K008 |
| Center Classification Date | 20210709 |
| Recall Initiation Date | 20210510 |
| Recalling Firm | IMPLANTCAST GMBH |
| Initial Notification | Letter |
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