Class II — Potential Health Hazard

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

Tibial knee prosthesis Recalled by Smith & Nephew, Inc. Due to Due to an inconsistency in the raw material...

Date: July 16, 2020
Company: Smith & Nephew, Inc.
Status: Ongoing
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

Tibial knee prosthesis

Quantity: 1,845 units

Why Was This Recalled?

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

Where Was This Sold?

This product was distributed to 25 states: AL, AZ, AR, CT, FL, GA, IN, IA, KY, LA, MA, MI, MN, MO, NV, NJ, NY, NC, OH, PA, SC, TN, TX, WV, WI

Affected (25 states)Not affected

About Smith & Nephew, Inc.

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

Related Recalls

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