Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2095-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 26, 2016

Date Posted: July 6, 2016

Recall Number: Z-2095-2016

Event ID: 74271

Reason for Recall:

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

Status: Terminated

Product Quantity: 97 units

Code Information:

Lot codes: 15JM04561,15JM04570,15JM04589,15KM08936,15KM08937,15KM08940,15KM08942,15KM08948,15KM08949,15KM09010,15KM09011,15KM09013,15KM09014,15KM09015,15KM09016,15LM09119,15LM09122,15LM09123,15LM09124,15LM12483,15LM12484,15LM12486,15LM12488,15LM15652,15MM09829,15MM09833,16AM12222,16AM12224,16AM12235,16AM12237,16AM12240,16AM12243,16AM12255,16AM12268

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated