Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & N…

Recall date

March 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1542-2016

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

International Distribution only in countries of: Germany and Switzerland.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis