Class II — Potential Health Hazard

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

TC-PLUS(TM) Recalled by Smith & Nephew, Inc. Due to The Affected Devices may contain a dimensional deviation...

Date: March 11, 2016
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

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Quantity: 24 units

Why Was This Recalled?

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Where Was This Sold?

International Distribution only in countries of: Germany and Switzerland.

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