The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2092-2016·Announced 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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (surface below specification) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 33 units of the LEGION(TM) HK FEMORAL ASSEMBLY, Size 4 Left. The recall affects specific lot codes listed in the agency record. The product is a medical device indicated for various forms of arthritis and failed knee replacements, intended for cemented use only.

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

The affected units were distributed worldwide, including in the United States (nationwide including Puerto Rico) and in Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and the UK. Healthcare providers and patients should contact Smith & Nephew for instructions on how to proceed.

The recalled product

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…
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
33

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 (18)

  • Lot codes: 15KM09161
  • 15KM09163
  • 15KM09175
  • 15KM17714
  • 15KM17800
  • 15KM17806
  • 15KM17809
  • 15KM17817
  • 15LM01258
  • 15LM01259
  • 15LM01260
  • 15LM01261
  • 15LM08803
  • 15LM08816
  • 15LM08820
  • 15LM08821
  • 71421375
  • 15KM09183

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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