The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2091-2016·Announced 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.

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, and the source text does not report any injuries, illnesses, or deaths. The hazard is a manufacturing specification issue regarding surface quality, which fits the criteria for a moderate severity recall without reported harm.

Plain-English summary

Smith & Nephew, Inc. is recalling 3 units of the LEGION HK Femoral Assembly, Size 3 Right, A/P 54.5 MM, M/L 62 MM, Reference 71421363. The specific lot code for the affected units is 15LM08798.

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 intended adhesion of the cement used to secure the implant.

The affected devices were distributed worldwide and in the US nationwide, including Puerto Rico, as well as 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 with the recall.

The recalled product

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…
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3

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 (1)

  • Lot Code: 15LM08798

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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