The Recall Desk

FDA (Devices) recall action 74271

Smith & Nephew, Inc. recalled 6 products on 2016-07-06

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-07-06
Critical
0
Units
171

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 10 units of Legion HK Femoral Assemblies because the internal cement surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-07-06

    Smith & Nephew Legion Hinge Knee Femoral Assembly Recall

    Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 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…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 97 units of the Legion HK Femoral Assembly because the internal surface is below specification, potentially affecting cement adhesion.

    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…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-07-06

    Smith & Nephew Recalls Legion Hinge Knee Femoral Assemblies

    Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 16 units of the Legion HK Femoral Assembly because the internal surface where cement is applied is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-07-06

    Smith & Nephew Recalls Legion HK Femoral Assemblies for Surface Defect

    Smith & Nephew is recalling 12 units of Legion HK Femoral Assemblies because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 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…
    Category
    Distribution
    1 state