FDAMay 10, 2021device

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 d...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

implantcast

UPCs

040488440053680404884400537504048844005382040488440053990404884400540504048844005412040488440054290404884400543604048844005443040488440054500404884400546704048844005474

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDA2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 024246522017-12-28

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →