The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0591-2015·Announced 2014-12-17

Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

Smith & Nephew is recalling 23 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a structural defect in a medical device is assigned a severity score of 4 (Severe).

Plain-English summary

Smith & Nephew, Inc. is recalling 23 units of the Legion COCR Constrained Femoral Component, Size 6, Left (Ref 71426006). The recall is due to a manufacturing defect where the stem taper on the device is undersized and the gauge point is not deep enough.

The affected units, identified by Lot Number 14EM23391, were distributed nationwide in the United States, including in Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Iowa, and Tennessee. The devices were also distributed internationally to Switzerland, Canada, Colombia, Germany, Dubai (UAE), Thailand, South Africa, South Korea, and Singapore.

Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew for instructions on how to return them.

The recalled product

Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
23

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 Number 14EM23391

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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