Stanmore Implants Worldwide Ltd. recalls METS SMILES Total Knee Replacement

Recall date

May 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2553-2016

FDA classification

Class II

Brand / firm

Stanmore Implants Worldwide Ltd.

Sold / distributed

Directly distributed to TX, further distributed to AL and MS

Why it was recalled

The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

METS SMILES Total Knee Replacement