Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING Recalled by Smith & Nephew, Inc. Due to A single lot of GENESIS II FEMORAL FIVE...

Date: April 9, 2018
Company: Smith & Nephew, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.

Affected Products

smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

Quantity: 18 units

Why Was This Recalled?

A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

Where Was This Sold?

This product was distributed to 9 states: CA, CO, GA, IN, MA, MI, NY, NC, PA

Affected (9 states)Not affected

About Smith & Nephew, Inc.

Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report