The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0590-2015·Announced 2014-12-17

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

Smith & Nephew is recalling 45 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, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences or structural defects in medical devices are rated as Severe (4).

Plain-English summary

Smith & Nephew, Inc. is recalling 45 units of the Legion COCR Constrained Femoral Component, Size 5, Right (Ref 71426005). The recall affects specific lot numbers: 14EM16708, 14EM21988, and 14DM22269.

The recall was initiated because the stem taper on the device is undersized and the gauge point is not deep enough. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected products were distributed nationwide in the United States, including in Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Iowa, and Tennessee. They were also distributed internationally to Switzerland, Canada, Colombia, Germany, Dubai (UAE), Thailand, South Africa, South Korea, and Singapore. Healthcare providers and patients should contact Smith & Nephew for further instructions on the recall.

The recalled product

Product
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
45

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 (3)

  • Lot Numbers: 14EM16708
  • 14EM21988
  • 14DM22269

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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