Smith & Nephew, Inc. recalls JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 7402111…

Recall date

June 13, 2018

Source

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

Recall number

Z-0002-2019

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.

Why it was recalled

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

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

What was recalled

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149