The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2095-2016·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a manufacturing defect (surface below specification) that poses a theoretical risk to cement adhesion, fitting the criteria for a moderate severity score where risk is present but harm is not yet reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 97 units of the LEGION HK Femoral Assembly, Size 5 Right, A/P 62 MM, M/L 70 MM, Reference 71421365. The recall is due to a manufacturing defect where the surface inside the femoral component, which is used for cement adhesion, is below specification.

The affected product is the LEGION Hinge Knee System, indicated for use in patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, as well as for failed osteotomies or previous knee replacements. The system is designed for cemented use only in primary and revision surgery.

The recall covers units distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and the UK. Specific lot codes are listed in the official recall notice. Healthcare providers should stop using the affected units and contact Smith & Nephew for instructions on return or replacement.

The recalled product

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…
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
97

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 (20)

  • Lot codes: 15JM04561
  • 15JM04570
  • 15JM04589
  • 15KM08936
  • 15KM08937
  • 15KM08940
  • 15KM08942
  • 15KM08948
  • 15KM08949
  • 15KM09010
  • 15KM09011
  • 15KM09013
  • 15KM09014
  • 15KM09015
  • 15KM09016
  • 15LM09119
  • 15LM09122
  • 15LM09123
  • 15LM09124
  • 15LM12483

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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