Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indi

Recalled July 6, 2016 · FDA recall Z-2095-2016 · Smith & Nephew

Hazard

The surface inside of the femoral component, where cement is applied for adhesion, is below specification. · FDA Class II

Units

97 units

Sold at

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

Description

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Product

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Manufacturer(s)

Smith & Nephew, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →