The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0589-2015·Announced 2014-12-17

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

Smith & Nephew is recalling 24 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 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 is classified as FDA Class II. Per the rubric, a Class II recall involving a risk-of-harm product where injury has not yet been reported is assigned a score of 3 (High).

Plain-English summary

Smith & Nephew, Inc. is recalling 24 units of the Legion COCR Constrained Femoral Component, Size 4, Left (Reference 71425004). 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 devices, identified by Lot Number 14FM05730, were distributed nationwide in the United States, specifically 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 who have purchased or received these specific knee prosthesis components should contact Smith & Nephew for instructions on how to return the product or obtain a replacement.

The recalled product

Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
24

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 14FM05730

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 →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls