Recall Z-2050-2021
Implantcast GmbH · initiated May 10, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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;
Codes / lots: 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:…
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.
FDA-determined cause: Device Design
Action taken
On May 10, 2021 Urgent Safety Information notices were emailed to customers who were asked to take the following action: 1. Read this safety information carefully and make sure all relevant departments and officeholders are informed about its content. 2. Keep this safety information. 3. Fill in and return the reply form. Customers with additional questions were encouraged to contact Wendy Ryan-Kettler at WRyan@implantcast-na.com On 17 May, 2017, a follow-up Medical Device Correction notice was emailed to customers who were asked to take the following additional actions: 4. Destroy the affected (previous) surgical technique and instruction for use (IFU) and replace them with the updated versions that accompanied this safety information.
Details
- Recall number
- Z-2050-2021
- Initiated
- May 10, 2021
- Posted by FDA
- July 9, 2021
- Terminated
- November 18, 2022
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 41 units (U.S.)
- Distribution
- U.S. Nationwide distribution in the states of FL and TX.
- Recalling firm
- Implantcast GmbH, Buxtehude