Smith & Nephew, Inc. recalls Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers:…

Recall date

October 20, 2015

Source

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

Recall number

Z-0372-2016

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

International only Germany, Japan, Russia

Why it was recalled

The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

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

What was recalled

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate