The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2093-2016·Announced 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.

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 (below specification surface) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Smith & Nephew, Inc. is recalling 16 units of the LEGION(TM) HK FEMORAL ASSEMBLY, Size 4 Right, A/P 58.5 MM, M/L 66 MM, Ref 71421364. The recall involves specific lot codes: 15KM20807, 15KM20808, 15KM20811, 15KM20812, 15LM08258, 15LM12482, 15MM03005, and 15MM03007.

The recall is due to a manufacturing defect where the surface inside the femoral component, which is used for cement adhesion, is below specification. This defect could potentially affect the stability of the implant in patients.

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

The recalled product

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…
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
16

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 (8)

  • Lot codes: 15KM20807
  • 15KM20808
  • 15KM20811
  • 15KM20812
  • 15LM08258
  • 15LM12482
  • 15MM03005
  • 15MM03007

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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