Smith & Nephew, Inc. recalls smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrumen…

Recall date

November 11, 2019

Source

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

Recall number

Z-0696-2020

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.

Why it was recalled

There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

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 PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.