Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm Recalled by IMPLANTCAST GMBH Due to A risk exists during impacting of the acetabular...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact IMPLANTCAST GMBH directly.
Affected Products
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;
Quantity: 41 units (U.S.)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About IMPLANTCAST GMBH
IMPLANTCAST GMBH has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report