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
Check against the official notice below — it lists the full affected range.
ImplantCast GmbH is recalling EcoFit cup cementless hip implants in sizes 46mm, 48mm, 50mm, and 52mm distributed nationwide in Florida and Texas. During surgical implantation, plugs on the acetabular cup may come loose from the cup when being impacted into the bone, which could extend the operation duration or require revision surgery. The risk is attributed to bone quality factors such as osteosclerosis. A total of 41 units were affected across multiple lot numbers.
The manufacturer is adding warning notes to the instructions for use and surgical technique to alert surgeons about this risk and the role of patient bone quality. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: U.S. Nationwide distribution in the states of FL and TX. Quantity: 41 units (U.S.) Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.