The Recall Desk
ModerateFDA (Devices)·Z-2094-2016·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 10 units of the LEGION HK Femoral Assembly, Size 5 Left, A/P 62 MM, M/L 70 MM, Reference 71421375. The recall involves specific lot codes: 15KM09184, 15LM08835, 15LM08837, 15LM08839, and 15LM08840.

The recall was initiated because the surface inside the femoral component, where cement is applied for adhesion, is below specification. This defect may affect the intended adhesion of the implant.

The affected products were distributed worldwide and in the US nationwide, including Puerto Rico, as well as in Australia, Austria, Belgium, Canada, France, Germany, Italy, the Netherlands, South Africa, Sweden, and the UK. Healthcare providers and patients should contact Smith & Nephew for further instructions regarding the affected implants.

The recalled product

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 leve
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot codes: 15KM09184
  • 15LM08835
  • 15LM08837
  • 15LM08839
  • 15LM08840

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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